BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA

    MDR report key: 11490289 · Received March 15, 2021

    Report

    Report Number
    1920898-2021-00292
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 16, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/22/2021. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.4. MEDICAL DEVICE LOT #: 0099954. D.4. MEDICAL DEVICE EXPIRATION DATE: 6/30/2025. H.4. DEVICE MANUFACTURE DATE: 4/8/2020. D.4. MEDICAL DEVICE LOT #: 0160417. D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2025. H.4. DEVICE MANUFACTURE DATE: 6/8/2020. D.4. MEDICAL DEVICE LOT #: 8302667. D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2024. H.4. DEVICE MANUFACTURE DATE: 10/29/2018. D.4. MEDICAL DEVICE LOT #: 8351757 D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2024 H.4. DEVICE MANUFACTURE DATE: 12/17/2018 D.4. MEDICAL DEVICE LOT #: 9119537. D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2024. H.4. DEVICE MANUFACTURE DATE: 4/29/2019. D.4. MEDICAL DEVICE LOT #: 9140521. D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2024. H.4. DEVICE MANUFACTURE DATE: 5/20/20219. D.4. MEDICAL DEVICE LOT #: 9168926. D.4. MEDICAL DEVICE EXPIRATION DATE: 9/30/2024. H.4. DEVICE MANUFACTURE DATE: 6/17/2019. D.4. MEDICAL DEVICE LOT #: 9189788. D.4. MEDICAL DEVICE EXPIRATION DATE: 9/30/2024. H.4. DEVICE MANUFACTURE DATE: 7/8/2019. D.4. MEDICAL DEVICE LOT #: 9196270. D.4. MEDICAL DEVICE EXPIRATION DATE: 10/31/2024. H.4. DEVICE MANUFACTURE DATE: 7/15/2019. D.4. MEDICAL DEVICE LOT #: 9231122. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2024. H.4. DEVICE MANUFACTURE DATE: 8/19/2019. D.4. MEDICAL DEVICE LOT #: 9287332. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2024. H.4. DEVICE MANUFACTURE DATE: 10/14/2019. D.4. MEDICAL DEVICE LOT #: 9294983. D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2024. H.4. DEVICE MANUFACTURE DATE: 10/21/2019. H.6. INVESTIGATION: CUSTOMER RETURNED (5) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 9231122. CUSTOMER STATES THAT THE SCALE MARKINGS ARE DEFECTIVE. ALL RETURNED SYRINGES WERE EXAMINED AND NO DEFECTIVE SCALE MARKINGS WERE OBSERVED. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FROM LOT # 9287332 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. CUSTOMER RETURNED (37) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS WITH THE SHELF CARTON FROM LOT # 9294983. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND THAT THE SCALE MARKINGS ARE DEFECTIVE. ALL RETURNED SYRINGES WERE EXAMINED. NO DAMAGED PLUNGER ROD WAS OBSERVED AND NO DEFECTIVE SCALE MARKINGS WERE OBSERVED. CUSTOMER RETURNED (3) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 9322637. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND THAT THE SCALE MARKINGS ARE DEFECTIVE. ALL RETURNED SYRINGES WERE EXAMINED. NO DAMAGED PLUNGER ROD WAS OBSERVED AND NO DEFECTIVE SCALE MARKINGS WERE OBSERVED. CUSTOMER RETURNED (33) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 8351757. CUSTOMER STATES THAT THE SCALE MARKINGS ARE DEFECTIVE AND THAT THE PLUNGER IS DAMAGED. ALL RETURNED SYRINGES WERE EXAMINED AND NO DEFECTIVE SCALE MARKINGS OR DAMAGE TO THE PLUNGER ROD WERE OBSERVED. CUSTOMER RETURNED (3) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 9119537 AND A PHOTO OF A 1CC SYRINGE. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND SCALE MARKINGS ARE DEFECTIVE. ALL RETURNED SYRINGES AND THE PHOTO WERE EXAMINED AND NO DAMAGED PLUNGER ROD OR DEFECTIVE SCALE MARKING WERE OBSERVED. CUSTOMER RETURNED (14) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 9140521. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND THAT THE SCALE MARKINGS ARE DEFECTIVE. ALL RETURNED SYRINGES WERE EXAMINED AND NO DAMAGED PLUNGER ROD OR DEFECTIVE SCALE MARKINGS WERE OBSERVED. CUSTOMER RETURNED (19) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 9168926. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND THE SCALE MARKINGS ARE DEFECTIVE. ALL RETURNED SYRINGES WERE EXAMINED AND NO DAMAGED PLUNGER OR DEFECTIVE SCALE MARKINGS WERE OBSERVED. CUSTOMER RETURNED (28) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS WITH THE SHELF CARTON FROM LOT # 9189788. CUSTOMER STATES THAT THE PLUNGER WAS DAMAGED AND THAT THE SCALE MARKINGS ARE DEFECTIVE. ALL RETURNED SYRINGES WERE EXAMINED AND NO DAMAGED PLUNGER OR DEFECTIVE SCALE MARKINGS WERE OBSERVED. CUSTOMER RETURNED (26) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 9196270. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND THE SCALE MARKINGS WERE DEFECTIVE. ALL RETURNED SYRINGES WERE EXAMINED AND NO DAMAGED PLUNGER ROD OR DEFECTIVE SCALE MARKINGS WERE OBSERVED. CUSTOMER RETURNED (15) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS WITH THE SHELF CARTON FROM LOT # 0099954. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND THAT THE SCALE MARKINGS ARE DEFECTIVE. ALL RETURNED SYRINGES WERE EXAMINED AND NO DAMAGED PLUNGER ROD OR DEFECTIVE SCALE MARKINGS WERE OBSERVED. CUSTOMER RETURNED (338) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS WITH THE SHELF CARTON FROM LOT # 0160417. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND THAT THE SCALE MARKINGS ARE DEFECTIVE. THIRTY OUT OF 338 RETURNED SYRINGES WERE EXAMINED AND NO DAMAGED PLUNGER ROD OR DEFECTIVE SCALE MARKINGS WERE OBSERVED. CUSTOMER RETURNED (23) EMPTY BLISTER PACKS FOR 1CC, 12.7MM, 28G SYRINGES WITH THE SHELF CARTON FROM LOT # 8302667. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED. ONLY EMPTY BLISTER PACKS WERE RETURNED FROM LOT # 8302667. NO SYRINGES WERE RETURNED FROM LOT # 8302667. CUSTOMER RETURNED (5) 1CC, 12.7MM, 28G SYRINGES IN BLISTER PACKS FROM LOT # 9231122. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED. ALL RETURNED SYRINGES WERE EXAMINED AND NO DAMAGED PLUNGER ROD WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231122. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9287332. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR MISSING PRINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9294983. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9322637. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8351757. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR DAMAGED PLUNGER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9119537. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9140521. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9168926. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9189788. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9196270. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0099954. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED FOR MISSING PRINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160417. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8302667. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231122. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 467 SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA EXPERIENCED SCALE MARKING ISSUES AND BROKEN/DAMAGED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329424 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE PLUNGER IS DAMAGED AND SCALE MARKINGS ARE ERASED OR IRREGULAR. PLUNGER IS DAMAGED AND IN MANY CASES, GRADUATIONS ARE ERASED OR IRREGULAR.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: A PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A 1CC SYRINGE IN AN OPENED BLISTER PACK FROM LOT # UNKNOWN, REGARDING ITEM # 305930 WITH THE REPORTED ISSUE THAT, ¿THE PLUNGER IS DAMAGED AND SCALE MARKINGS ARE ERASED OR IRREGULAR¿. THE PHOTOS OF THE 10ML SYRINGES WERE INVESTIGATED UNDER COMPLAINT # (B)(4). THE PHOTO OF THE 1ML SYRINGE WAS EXAMINED AND NO DEFECTS TO THE PLUNGER OR SCALE MARKINGS WERE OBSERVED. A DHR CHECK WAS NOT PERFORMED AS THE LOT NUMBER IS "UNKNOWN" FOR THIS COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS NOT PERFORMED AS THE LOT NUMBER IS "UNKNOWN" FOR THIS COMPLAINT. CUSTOMER RETURNED A PHOTO OF A 1CC SYRINGE IN AN OPENED BLISTER PACK. CUSTOMER STATES THAT THE PLUNGER IS DAMAGED AND SCALE MARKINGS ARE ERASED OR IRREGULAR. THE PHOTO OF THE 1ML SYRINGE WAS EXAMINED AND NO DEFECTS TO THE PLUNGER OR SCALE MARKINGS WERE OBSERVED. UNABLE TO COMPLETE DHR REVIEW AS THE LOT NUMBER IS UNKNOWN. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 467 SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA EXPERIENCED SCALE MARKING ISSUES AND BROKEN/DAMAGED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329424 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE PLUNGER IS DAMAGED AND SCALE MARKINGS ARE ERASED OR IRREGULAR. PLUNGER IS DAMAGED AND IN MANY CASES, GRADUATIONS ARE ERASED OR IRREGULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376304 SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1