BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Report
- Report Number
- 2243072-2021-02919
- Event Type
- Malfunction
- Date Received
- December 14, 2021
- Date of Event
- November 18, 2021
- Report Date
- January 27, 2022
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. H3 OTHER TEXT : SEE H.10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 2 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES HAD A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED TWO SYRINGES WITH A DAMAGED STOPPER. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE. D.1. MEDICAL DEVICE BRAND NAME: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL - DIABETES CARE (HOLDREGE). D.4. MEDICAL DEVICE CATALOG #: 328468. D.4. MEDICAL DEVICE LOT #: 1095772. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D.4. MEDICAL DEVICE EXPIRATION DATE: 4/30/2026. D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/6/2022. G.1. MANUFACTURING LOCATION: BD MEDICAL - DIABETES CARE (HOLDREGE). G.4. PMA / 510(K)#: K024112. H.4. DEVICE MANUFACTURE DATE: 4/5/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (2) LOOSE 0.5ML BD INSULIN SYRINGES FROM LOT# 1095772. THE CUSTOMER REPORTED THAT A SYRINGE WAS MISSING A NEEDLE, AND TWO SYRINGES HAD A DAMAGED STOPPER. THE RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT ONE SYRINGE EXHIBITED A DETACHED NEEDLE HUB/SHIELD ASSEMBLY. NO DAMAGE TO THE BARREL TIP WAS OBSERVED. NEITHER SYRINGE EXHIBITED A DAMAGED STOPPER, AND BOTH PLUNGER RODS WERE ABLE TO MOVE PROPERLY WITHIN THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1095772. 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. CAPA#1630423 WAS INITIATED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT 2 UNSPECIFIED BD¿ SYRINGES HAD A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED TWO SYRINGES WITH A DAMAGED STOPPER. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
IT WAS REPORTED THAT 2 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLES HAD A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED TWO SYRINGES WITH A DAMAGED STOPPER. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
IT WAS REPORTED THAT 2 UNSPECIFIED BD¿ SYRINGES HAD A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED TWO SYRINGES WITH A DAMAGED STOPPER. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1896631 | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 1095772 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |