BD¿ ALLERGY SYRINGE
Report
- Report Number
- 1920898-2021-01214
- Event Type
- Malfunction
- Date Received
- November 19, 2021
- Date of Event
- October 21, 2021
- Report Date
- December 1, 2021
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 30382903055419
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #1112184. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. 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. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.
DATE OF EVENT: UNKNOWN. 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 IN SOME CASES, THE INCORRECT NEEDLES WERE RECEIVED IN THE TRAY OF BD¿ ALLERGY SYRINGES. IN OTHER CASES, THE LABELING ON THE PACKAGING WAS INCORRECT OR MISSING INFORMATION. ADDITIONALLY, WHITE OR RED FIBERS WERE FOUND ON THE NEEDLE WHEN REMOVING THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN YOU OPEN UP EACH INDIVIDUAL TRAY SOME ARE ACTUALLY THE TESTING NEEDLES (1/2 ML 27G 3/8). WE HAVE SEEN THIS MULTIPLE TIMES, AS WELL AS THE OPPOSITE WAY, WHERE WE ORDER TESTING NEEDLES. IT SAYS TESTING ON THE SHIPPING BOX, BUT OPEN EACH INDIVIDUAL TRAY AND IT IS TREATMENT NEEDLES INSTEAD OF TESTING. WE HAVE ALSO HAD A FEW INDIVIDUAL TRAYS THAT HAVE NO LABEL OR PRINT ON THEM OTHER THAN THE LOT AND EXPIRATION DATE. SOMETHING EVEN MORE CONCERNING IS THAT WE HAVE FOUND SO MANY TREATMENT NEEDLES THAT WHEN WE PULL OFF THE CAP, THERE IS WHITE OR RED FIBERS ON THE NEEDLE."
IT WAS REPORTED THAT IN SOME CASES, THE INCORRECT NEEDLES WERE RECEIVED IN THE TRAY OF BD¿ ALLERGY SYRINGES. IN OTHER CASES, THE LABELING ON THE PACKAGING WAS INCORRECT OR MISSING INFORMATION. ADDITIONALLY, WHITE OR RED FIBERS WERE FOUND ON THE NEEDLE WHEN REMOVING THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN YOU OPEN UP EACH INDIVIDUAL TRAY SOME ARE ACTUALLY THE TESTING NEEDLES (1/2 ML 27G 3/8). WE HAVE SEEN THIS MULTIPLE TIMES, AS WELL AS THE OPPOSITE WAY, WHERE WE ORDER TESTING NEEDLES. IT SAYS TESTING ON THE SHIPPING BOX, BUT OPEN EACH INDIVIDUAL TRAY AND IT IS TREATMENT NEEDLES INSTEAD OF TESTING. WE HAVE ALSO HAD A FEW INDIVIDUAL TRAYS THAT HAVE NO LABEL OR PRINT ON THEM OTHER THAN THE LOT AND EXPIRATION DATE. SOMETHING EVEN MORE CONCERNING IS THAT WE HAVE FOUND SO MANY TREATMENT NEEDLES THAT WHEN WE PULL OFF THE CAP, THERE IS WHITE OR RED FIBERS ON THE NEEDLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1745425 | BD¿ ALLERGY SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 305541 | 1112184 | 30382903055419 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |