BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
Report
- Report Number
- 1920898-2020-00227
- Event Type
- Malfunction
- Date Received
- March 10, 2020
- Date of Event
- February 25, 2020
- Report Date
- April 15, 2020
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249107
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6 INVESTIGATION SUMMARY : CUSTOMER RETURNED (4) 3/10CC, 6MM, 31G SYRINGES IN OPEN POLY BAGS WITH THE SHELF CARTON FROM LOT # 9070627. CUSTOMER STATES THAT SHE WAS NOT ABLE TO REMOVE THE SHIELD FROM 2 SYRINGES, SHIELD IS DIFFICULT TO REMOVE FROM MOST OF HER SYRINGES, WHEN SHE REMOVED SHIELD, NEEDLE WAS STUCK INSIDE, AND THE NEEDLE WAS BENT. ONE SYRINGE WAS RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. ALL REMAINING SYRINGES WERE TESTED TO DETERMINE THE SHIELD REMOVAL FORCES (SPECS: SHIELD REMOVAL FORCE FOR 3/10CC AFTER STERILIZATION: 0.85-5.95 LBS.). DATA: SHIELD REMOVAL FORCE SYRINGE 1, 2.33 LBS. SYRINGE 2, 3.08 LBS. SYRINGE 3, 2.10 LBS. THE REMOVAL FORCES FALL WITHIN SPECIFICATION. ALSO, NO BENT CANNULA WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070627. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [200819499, 200818801, 200819730, 200819826] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES, SHIELD DIFFICULT TO REMOVE) UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT CANNULA) ON 07 APR 2020, HOLDREGE RECEIVED PHOTO COMPLAINT. A VISUAL EVALUATION OF PHOTO FOUND (1) SYRINGE WITH NO NEEDLE ASSEMBLIES ATTACHED. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE TIP OF THE BARREL, OR ANYWHERE ON THE SYRINGE. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE CORE PIN. PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 3/10CC, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. ROOT CAUSE: THE NEEDLE ASSEMBLY PRESS STATION WAS OUT OF ADJUSTMENT. L2L DISPATCH #65105 WAS CREATED FOR REJECT EYE TIMING BEING OFF/OUT OF TIME. CORRECTIVE ACTION: ADJUSTED THE REJECT EYE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. TIP-2019-37 WAS IMPLEMENTED ON (B)(6) 2019 FOR INCREASED SAMPLING FOR NEEDLE HUB SEPARATES IN 0.3ML. CAPA1122103 WAS BEEN OPENED ON (B)(6) 2019 TO ADDRESS THIS ISSUE." 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. D.4. MEDICAL DEVICE LOT #: 9070627. H.4. DEVICE MANUFACTURE DATE: 2019-03-11.
IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATES FROM THE DEVICE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324910 BATCH NO: UNKNOWN IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO REMOVE THE SHIELD FROM 2 SYRINGES, SHIELD IS DIFFICULT TO REMOVE FROM MOST OF HER SYRINGES. STATED, WHEN SHE REMOVED SHIELD, NEEDLE WAS STUCK INSIDE. DID NOT TRY TO REMOVE, (1 SYRINGE AFFECTED). STATED, FINDING BENT NEEDLES AFTER REMOVING SHIELD, SHE DOES NOT USE IF BENT.
IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATES FROM THE DEVICE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324910 BATCH NO: 9070627. IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO REMOVE THE SHIELD FROM 2 SYRINGES, SHIELD IS DIFFICULT TO REMOVE FROM MOST OF HER SYRINGES. STATED, WHEN SHE REMOVED SHIELD, NEEDLE WAS STUCK INSIDE. DID NOT TRY TO REMOVE, (1 SYRINGE AFFECTED). STATED, FINDING BENT NEEDLES AFTER REMOVING SHIELD, SHE DOES NOT USE IF BENT.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR SHIELD DOES NOT DETACH AS INTENDED, NEEDLE HUB SEPARATES AND NEEDLE BENT (BEFORE USE) DUE TO UNKNOWN LOT NUMBER. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR CHECK FOR SHIELD DOES NOT DETACH AS INTENDED, NEEDLE HUB SEPARATES AND NEEDLE BENT (BEFORE USE) DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.
IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATES FROM THE DEVICE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324910 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO REMOVE THE SHIELD FROM 2 SYRINGES, SHIELD IS DIFFICULT TO REMOVE FROM MOST OF HER SYRINGES. STATED, WHEN SHE REMOVED SHIELD, NEEDLE WAS STUCK INSIDE. DID NOT TRY TO REMOVE, (1 SYRINGE AFFECTED). STATED, FINDING BENT NEEDLES AFTER REMOVING SHIELD, SHE DOES NOT USE IF BENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277419 | BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 324910 | 9070627 | 00382903249107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |