1920898-2018-00827
Report
- Report Number
- 1920898-2018-00827
- Event Type
- Malfunction
- Date Received
- November 2, 2018
- Date of Event
- October 16, 2018
- Report Date
- December 5, 2018
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 12.7MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 7240944. CUSTOMER STATES THAT THE NEEDLE WAS STICKING THROUGH THE BAG AND STUCK THEM IN THE HAND WHERE THERE WAS BLOOD, THE SHIELD WAS LOOSE IN THE BAG, THE NEEDLE WAS BENT, AND THE PLUNGER ROD AND THE BARREL WERE CRACKED. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A CRACK IN THE BARREL RUNNING FROM THE 10-35 UNIT MARKINGS. NO DAMAGE WAS OBSERVED ON THE PLUNGER ROD. THE SHIELD WAS RETURNED ON THE HUB COVERING THE CANNULA. HOWEVER, THE CANNULA WAS OBSERVED TO BE BENT. SAMPLE WAS FORWARDED TO MANUFACTURING (HOLDREGE) ON 21NOV2018 FOR FURTHER REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240944. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE NINE (9) NOTIFICATIONS THAT DID NOT PERTAIN TO THE COMPLAINT. THE RETURNED SAMPLE WAS NOTED TO HAVE A DAMAGED CANNULA SHIELD, CAUSING THE COMPONENT TO APPEAR AS THOUGH IT WAS BENT TO ONE SIDE. THIS DAMAGE AND THE DIRECTION OF THE SHIELD MAY ACCOUNT FOR THE SLIGHT BEND NOTED PREVIOUSLY OF THE CANNULA. THE RETURNED SAMPLE WAS EVALUATED ON A COMPARATOR WITHIN THE HOLDREGE PLANT'S METROLOGY DEPARTMENT AND NOTED THE ANGULARITY OF THE CANNULA TO BE ~3.18°. THIS FINDING IS WITHIN THE DEVICE SPECIFICATIONS, WHICH CALLS FOR NO MORE THAN A ±7° ANGLE OF THE CANNULA SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE STICK BEFORE USE, SHIELD SEPARATED, NEEDLE BENT, PLUNGER ROD CRACKED, BARREL CRACKED AND BLEEDING ON LOT # 7240944. GIVEN THIS INFORMATION, THE BENT CANNULA ISSUE WILL NOT BE CONFIRMED WHILE THE DAMAGED SHIELD ISSUE WILL BE CONFIRMED. PROBABLE ROOT CAUSE FOR THE DAMAGE NOTED TO THE SHIELD AND SYRINGE BARREL IS LIKELY TO BE A JAM ON THE METRO DURING ASSEMBLY. THIS TYPE OF EVENT CAN CAUSE STRESS TO THE COMPONENTS AS THEY ARE TRANSFERRED FROM ONE DIAL TO THE NEXT, AND SHOULD THIS PROCESS BE HALTED ABRUPTLY, DAMAGE TO ANY PORTION OF THE DEVICE CAN OCCUR. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT CANNULA, NEEDLE STICK, BLEEDING, CRACKED BARREL). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SHIELD LOOSE, CRACKED PLUNGER ROD). 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. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME.
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# 7240944. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE NINE (9) NOTIFICATIONS [200715117, 200715768, 200715109, 200715108, 200713390, 200715412, 200713372, 200714176, 200714324,] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE STICK BEFORE USE, SHIELD SEPARATED, NEEDLE BENT, PLUNGER ROD CRACKED, BARREL CRACKED AND BLEEDING ON LOT # 7240944. 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. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
VIT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HAD A CRACKED PLUNGER ROD, A CRACKED BARREL, STERILITY BREACH, AND DETACHED SHIELD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE HAD A CRACKED PLUNGER ROD, A CRACKED BARREL, STERILITY BREACH, AND DETACHED SHIELD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HAD A CRACKED PLUNGER ROD, A CRACKED BARREL, STERILITY BREACH, AND DETACHED SHIELD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |