SEE H10
Report
- Report Number
- 1920898-2022-00453
- Event Type
- Malfunction
- Date Received
- July 15, 2022
- Date of Event
- June 15, 2022
- Report Date
- July 20, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382903249091
- PMA / PMN Number
- K212499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- 003
Narratives
MEDICAL DEVICE BRAND NAME: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM. INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RETURNED FOR EVALUATION. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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. A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 1200343 FOR DIFFICULT/UNABLE TO OPERATE (NOT DRAWING). THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE (NOT DRAWING) ON LOT # 1200343. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1200343. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200974343] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SINCE NO SAMPLES AND/OR PHOTO(S) OF THE SAMPLES WERE RECEIVED FOR INVESTIGATION, EMBECTA WAS NOT ABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THE ISSUE CANNOT BE CONFIRMED AS NO SAMPLES OR IMAGES WERE RETURNED FOR EVALUATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.
H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 0.3ML BD INSULIN SYRINGES FROM LOT# 1200343. THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO PUSH ALL THE AIR INTO THEIR VIAL WHEN DRAWING INSULIN, AND GETS A LARGE VOID WHEN DRAWING INTO THE SYRINGE. BOTH SAMPLES WERE EXAMINED, THEN TESTED FOR FLOW: BOTH SYRINGES WERE ABLE TO DRAW AND EXPEL PROPERLY. NO DEFECTS TO THE STOPPER OR PLUNGER ROD WERE OBSERVED ON EITHER SYRINGE. THE ALLEGED ISSUES COULD NOT BE CONFIRMED BASED ON THE SAMPLES PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1200343. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA 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. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT 2 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES 3/10ML 6MM EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED 2 SYRINGES WHERE WHEN PLACING THE AIR EQUAL AMOUNTS AIR VERSES INSULIN, CANT PUSH ALL THE AIR INTO VIAL.
IT WAS REPORTED THAT 2 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES 3/10ML 6MM EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED 2 SYRINGES WHERE WHEN PLACING THE AIR EQUAL AMOUNTS AIR VERSES INSULIN, CANT PUSH ALL THE AIR INTO VIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2884952 | SEE H10 | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 324909 | 1200343 | 00382903249091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |