BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 1920898-2018-00334
- Event Type
- Malfunction
- Date Received
- May 3, 2018
- Date of Event
- March 18, 2018
- Report Date
- September 17, 2018
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382908468039
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
Narratives
H.6. INVESTIGATION RESULTS: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7016809. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SYRINGE ASSEMBLY: THERE WERE TWO (2) BATCHES OF MATERIAL# 700005657(SYRINGE 0.5ML ASM 31G 8MM TW SM700178 SC) THAT WENT INTO THE FINISHED BATCH# 7016809. BATCH# 7052990. DATE(S) OF MANUFACTURE: 03MAR2017 THRU 07MAR2017. MACHINE(S) MANUFACTURED ON: (B)(4). BATCH# 7027697. DATE(S) OF MANUFACTURE: 26FEB2017 THRU 09MAR2017. MACHINE(S) MANUFACTURED ON: (B)(4). THERE WERE SEVEN (7) NOTIFICATIONS [200680931, 200680932, 200680412, 200680019, 200681432, 200680934] NOTED THAT DID NOT PERTAIN TO THE DEFECT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR PLUNGER DAMAGED ON LOT # 7016809. BASED ON THE SAMPLES / PHOTO(S) 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.
INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) LOOSE 1/2CC, 8MM SYRINGES. CUSTOMER STATES THAT THE PLUNGER LOOKS LIKE IT HAS BEEN MELTED DURING PRODUCTION. TWO SYRINGES WERE RETURNED WITH THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. NO DAMAGE TO THE BARREL WAS OBSERVED. ALL REMAINING SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A MISSING STOPPER. ONE SAMPLE EXHIBITED A DAMAGED SHIELD. TWO SAMPLES EXHIBITED A SCRATCHED BARREL. ONE SAMPLE EXHIBITED A CRUSHED THUMB PRESS ON THE PLUNGER ROD. CAPA 97451 HAS BEEN OPENED TO ADDRESS THE HUB SEPARATES ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7016809. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SEVEN (7) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE DEFECT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DAMAGED THUMB PRESS, DAMAGED SHIELD, MISSING STOPPER, HUB SEPARATES, AND SCRATCHED BARREL). INVESTIGATION CONCLUSION: POSSIBLE ROOT CAUSES FOR HUB SEPARATES ISSUE INCLUDE: BROKEN PLUNGER LODGED IN BETWEEN BARREL AND SHIELD CARRIERS MAY CAUSE INCOMPLETE SHIELD ASSEMBLIES. SYSTEMS WITH PLUNGER SCREW INFEED¿S HAVE A GREATER PROPENSITY FOR CREATING BROKEN PLUNGERS VERSUS MACHINES WITH DIAL INFEED¿S. A MISALIGNED LASER SENSOR (RAISED SHIELD) FROM ITS DESIGNATED DETECTING POSITION MAY RESULT IN SENDING DEFECTIVE PARTS WITH GATE FLASH AND/OR RAISED NEEDLE ASSEMBLIES TO PACKAGING AS GOOD PRODUCT. HUB CORE DAMAGE (EITHER FROM SEATING ON RACKS OR DURING ASSEMBLY ONTO BARREL), ADHESIVE RUN-OVER CAUSING EXCESSIVE FORCE REQUIRED TO REMOVE SHIELD, DISASSEMBLING HUB FROM THE SYRINGE. CAPA 97451 HAS BEEN OPENED TO ADDRESS THIS ISSUE. PROBABLE ROOT CAUSE FOR MISSING STOPPER: AT THE STOPPER ASSEMBLY ON THE METRO MACHINE AS THE DIAL FOR THE PLUNGER COMES AROUND FOR THE MARRIAGE OF THE STOPPER TO PLUNGER, A PLUNGER COULD GET HUNG UP IN THE DIAL AND NOT ALLOW THE STOPPER TO ASSEMBLE TO THE PLUNGER. POSSIBLE ROOT CAUSE FOR DAMAGED THUMB PRESS: THE SYRINGE WAS CAUGHT IN THE SEALING BARS OF THE PACKAGING MACHINE, CRUSHING THE CAP AND THE PLUNGER. POSSIBLE ROOT CAUSE FOR DAMAGED SHIELD: LIKELY A JAW JAM OF FORM FILL & SEAL AND THEN MADE IT TO PACKAGING. PROBABLE ROOT CAUSE: SCRATCHED BARREL IS DUE TO SYRINGE CONTACTING A MACHINE PART DURING CONVEYANCE OR ASSEMBLY AFTER PRINTING.
DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.
IT WAS REPORTED THAT BEFORE USE SEVERAL BD INSULIN SYRINGE'S WITH THE BD ULTRA-FINE¿ NEEDLE WERE FOUND WITH " THE PLUNGER LOOKS LIKE IT HAS BEEN MELTED DURING PRODUCTION." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
IT WAS REPORTED THAT BEFORE USE SEVERAL BD INSULIN SYRINGE'S WITH THE BD ULTRA-FINE NEEDLE WERE FOUND WITH " THE PLUNGER LOOKS LIKE IT HAS BEEN MELTED DURING PRODUCTION." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BEFORE USE SEVERAL BD INSULIN SYRINGE'S WITH THE BD ULTRA-FINE¿ NEEDLE WERE FOUND WITH " THE PLUNGER LOOKS LIKE IT HAS BEEN MELTED DURING PRODUCTION." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325048 | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE | INSULIN SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 7016809 | 00382908468039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |