BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
Report
- Report Number
- 2243072-2019-01596
- Event Type
- Malfunction
- Date Received
- August 5, 2019
- Date of Event
- July 21, 2019
- Report Date
- September 20, 2019
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.2. DATE OF EVENT: (B)(6) 2019. B.4. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE NEEDLE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS FOUND DAMAGED AND "SPLIT IN" DURING USE. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A CRACK IN THE SYRINGE BARREL, WHICH WAS FOUND WHILE ATTEMPTING TO DRAW INSULIN AND ENCOUNTERING NO RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE FOUND A BAD NEEDLE THAT HAS A SPLIT IN IT AND IT WAS A NEW BOX." "CONSUMER STATED, THERE IS A CRACK IN BARREL OF SYRINGE. STATED, WHEN DRAWING INSULIN, THERE WAS NO RESISTANCE, THAT'S WHEN SHE NOTICED THE CRACK." D.1. MEDICAL DEVICE BRAND NAME: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; D.2. MEDICAL DEVICE CATALOG#: 324909; D.2. MEDICAL DEVICE LOT#: 8337695; D.3. MEDICAL DEVICE MANUFACTURER: BD MEDICAL - DIABETES CARE; D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31; D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4); E.1. INITIAL REPORTER ADDRESS 1: (B)(6); E.1. INITIAL REPORTER ADDRESS 2: (B)(6); E.1. INITIAL REPORTER CITY: (B)(6); E.1. INITIAL REPORTER STATE: (B)(6); E.1. INITIAL REPORTER ZIP: (B)(6); F.10. DEVICE CODES: 1354, 2588; G.2. MANUFACTURING LOCATION: BD MEDICAL - DIABETES CARE; G.5. PMA / 510(K)#: K024112; H.4. DEVICE MANUFACTURE DATE: 2018-12-03 H3 OTHER TEXT : SEE SECTION H.10.
H.6. INVESTIGATION: H.6. INVESTIGATION: CUSTOMER RETURNED ONE LOOSE 31G X 6MM, 0.3ML BD INSULIN SYRINGE FROM LOT 8337695. CONSUMER REPORTED: THERE IS A CRACK IN BARREL OF SYRINGE; STATED, WHEN DRAWING INSULIN, THERE WAS NO RESISTANCE, THAT'S WHEN SHE NOTICED THE CRACK. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT THERE WERE TWO CRACKS IN THE BARREL OF THE SYRINGE. NO DAMAGE/ISSUES TO THE ACTUAL CANNULA WERE OBSERVED. THE SAMPLE WAS TESTED FOR FLOW USING WATER, AND IT WAS OBSERVED THAT THE SYRINGE WAS UNABLE TO DRAW WATER PAST THE POINT WHERE THE CRACKS IN THE BARREL WERE FORMED. THE CAUSE OF THE CRACKS IN THE SYRINGE BARREL LIKELY OCCURRED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8337695. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200802305] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (BARREL DAMAGED AND SYRINGE NOT DRAWING). BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CANNULA DAMAGED). H3 OTHER TEXT : SEE SECTION H.10
IT WAS REPORTED THAT THE NEEDLE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS FOUND DAMAGED AND "SPLIT IN" DURING USE. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A CRACK IN THE SYRINGE BARREL, WHICH WAS FOUND WHILE ATTEMPTING TO DRAW INSULIN AND ENCOUNTERING NO RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE FOUND A BAD NEEDLE THAT HAS A SPLIT IN IT AND IT WAS A NEW BOX." "CONSUMER STATED, THERE IS A CRACK IN BARREL OF SYRINGE. STATED, WHEN DRAWING INSULIN, THERE WAS NO RESISTANCE, THAT'S WHEN SHE NOTICED THE CRACK."
IT WAS REPORTED THAT THE NEEDLE OF THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS FOUND DAMAGED AND "SPLIT IN" DURING USE. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A CRACK IN THE SYRINGE BARREL, WHICH WAS FOUND WHILE ATTEMPTING TO DRAW INSULIN AND ENCOUNTERING NO RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE FOUND A BAD NEEDLE THAT HAS A SPLIT IN IT AND IT WAS A NEW BOX." "CONSUMER STATED, THERE IS A CRACK IN BARREL OF SYRINGE. STATED, WHEN DRAWING INSULIN, THERE WAS NO RESISTANCE, THAT'S WHEN SHE NOTICED THE CRACK."
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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT THE NEEDLE OF THE UNSPECIFIED BD¿ SYRINGE WITH NEEDLE WAS FOUND DAMAGED AND "SPLIT IN" DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE FOUND A BAD NEEDLE THAT HAS A SPLIT IN IT AND IT WAS A NEW BOX."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 657026 | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 8337695 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |