BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 1920898-2022-00415
- Event Type
- Malfunction
- Date Received
- June 27, 2022
- Date of Event
- May 29, 2022
- Report Date
- July 1, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382908468039
- PMA / PMN Number
- K190054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE CORRECTED: D9: DEVICE AVAILABLE FOR EVAL NO, D9: RETURNED TO MANUFACTURER ON: NA. H6: INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. FIVE PHOTOS OF A SHELF CARTON FOR BD INSULINS SYRINGES FROM LOT# 2020067 WERE PROVIDED. THE CUSTOMER REPORTED THAT THE SYRINGES ARE HARD TO PRESS, WOULD LEAK AND CAUSE MISCALCULATION OF DOSE. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT NO SYRINGES WERE SHOWN ¿ ONLY THE SHELF CARTON PACKAGING WAS CAPTURED. THE ALLEGED DEFECTS COULD NOT BE CONFIRMED BASED ON THE PHOTOS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2020067. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BASED ON THE PHOTOS RECEIVED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE ARE DIFFICULT TO MOVE WHICH RESULTS IN LEAKAGE AND MISS CALCULATION OF DOSAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGES ARE DIFFICULT TO MOVE WHICH RESULTS IN LEAKAGE AND MISS CALCULATION OF DOSAGE. COMPLAINED THAT THE SYRINGES ARE VERY HARD TO PRESS AND WHEN PRESSED THE SYRINGE WILL LEAK RESULTING IN MISS CALCULATION OF DOSAGE. REGISTERED NURSE - NO IMPACT TO PATIENT CUSTOMER COMPLAINT ABOUT LEAKAGE AND EASE OF USE.
IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE ARE DIFFICULT TO MOVE WHICH RESULTS IN LEAKAGE AND MISS CALCULATION OF DOSAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGES ARE DIFFICULT TO MOVE WHICH RESULTS IN LEAKAGE AND MISS CALCULATION OF DOSAGE. COMPLAINED THAT THE SYRINGES ARE VERY HARD TO PRESS AND WHEN PRESSED THE SYRINGE WILL LEAK RESULTING IN MISS CALCULATION OF DOSAGE. REGISTERED NURSE - NO IMPACT TO PATIENT CUSTOMER COMPLAINT ABOUT LEAKAGE AND EASE OF USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 734907 | BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 328468 | 2020067 | 00382908468039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |