BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
Report
- Report Number
- 1920898-2020-01139
- Event Type
- Malfunction
- Date Received
- August 29, 2020
- Date of Event
- August 6, 2020
- Report Date
- October 23, 2020
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00382908466035
- PMA / PMN Number
- K024112
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 11 SEPTEMBER 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7306959. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [200726680, 200727018, 200726569, 200726568] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE FOUR (4) NOTIFICATIONS [200726679, 200726719, 200726678, 200726717] NOTED FOR CRACKED HUBS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9259095. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.
CORRECTION: ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE BD INSULIN SYRINGE WHEN REMOVING THE SHIELD. ADDITIONALLY, THE PLUNGER ROD WAS ALSO BROKEN. THESE EVENTS EACH OCCURRED 2 TIMES IN LOT 7306959, 2 TIMES IN LOT 9259095, 2 TIMES IN LOT 7198837, AND 2 TIMES IN LOT 6242668. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 7306959. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-10-31. H.4. DEVICE MANUFACTURE DATE: 2017-11-02. D.4. MEDICAL DEVICE LOT #: 9259095 D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-09-30 H.4. DEVICE MANUFACTURE DATE: 2019-09-16 D.4. MEDICAL DEVICE LOT #: 7198837. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 2017-08-31. D.4. MEDICAL DEVICE LOT #: 6242668. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 2016-10-13. H.6. FDA PATIENT PROBLEM CODE: 1994.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/1/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (81) 30GX12.7MM, 0.5ML BD INSULIN SYRINGES FROM POLYBAGS FROM LOT 7198837, 6242668, 7306959 AND 9259095. CONSUMER REPORTED PAIN AND NEEDLES ARE BENDING WHEN TAKING INJECTION AND WHEN INSERTING INTO VIAL; STATED, NEEDLES ARE BENT ONCE SHE REMOVES THE SHIELD; STATED, NEEDLE HUB SEPARATED WHEN REMOVING THE SHIELD; STATED, SHIELDS DIFFICULT TO REMOVE. ALL 82 RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 41 SYRINGES WERE RETURNED AFTER USE. 1 SYRINGE EXHIBITED A BROKEN PLUNGER ROD. 30 OUT OF THE 81 RETURNED SYRINGES WERE TESTED FOR POINT GEOMETRY, OUTER DIAMETER, LUBE COVERAGE, AND SHIELD REMOVAL FORCE (SPECS: OUTER DIAMETER FOR 30G CANNULA: 0.0120¿- 0.0125¿; SHIELD REMOVAL FORCE FOR 0.5 ML SYRINGE AFTER STERILIZATION IS 0.85 TO 5.95LBS). ALL 30 TESTED SAMPLES TESTED WITHIN SPECIFICATION FOR POINT GEOMETRY, OUTER DIAMETER, LUBE COVERAGE, AND SHIELD REMOVAL FORCE. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THESE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7306959. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR (4) NOTIFICATIONS [(B)(6)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE FOUR (4) NOTIFICATIONS [(B)(6)] NOTED FOR CRACKED HUBS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9259095. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7198837. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [(B)(6)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [(B)(6)] NOTED FOR CRACKED HUBS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6242668. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. - CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN PLUNGER ROD) - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NEEDLES BENT, BENDING DURING USE, HUB SEPARATES, SHIELD DOES NOT DETACH) ASSEMBLY PROCESS SUMMARY: THE AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.5ML SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER/STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. PACKAGING PROCESS SUMMARY: A DIAL TRANSFERS THE CORRECT NUMBER OF SYRINGES TO A TUBE WHERE THEY DROP BY GRAVITY THROUGH THE TUBE COMING TO REST ON TOP OF THE POLYBAG SEALING JAWS. THE POLYBAG IS FORMED BY WEB THAT IS WRAPPED AROUND A METAL TUBE WHERE THE SIDES OF THE WEB OVERLAP AND ARE SEALED TO FORM THE VERTICAL SEAL. SEALING JAWS FORM THE POLYBAG BOTTOM, AS WELL AS THE TOP OF THE PREVIOUS POLYBAG. BETWEEN THE SEALING JAWS IS A KNIFE THAT SEVERS THE BAG FROM THE ROLL. ROOT CAUSE: L2L DISPATCH #79993 WAS OPENED FOR PLUNGERS GETTING STUCK ON THE RAIL. THE AIR JET WAS OUT OF ADJUSTMENT. CORRECTIVE ACTION: THE AIR JET WAS ADJUSTED.
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE BD INSULIN SYRINGE WHEN REMOVING THE SHIELD. THIS OCCURRED 2 TIMES IN LOT 7306959 , AND 2 TIMES IN LOT 9259095. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NEEDLES ARE BENDING WHEN TAKING INJECTION. STATED, SOME NEEDLES ARE BENDING WHEN INSERTING INTO VIAL. STATED, NEEDLES ARE BENT ONCE SHE REMOVES THE SHIELD, (NEW OUT OF BAG). STATED, NEEDLE HUB SEPARATED WHEN REMOVING THE SHIELD. STATED, SHIELDS DIFFICULT TO REMOVE. STATED, DOES NOT RE-USE AND WILL ROTATE SITES. STATED, SHE HAD THESE DIFFERENT ISSUES ON AND OFF FOR MONTHS."
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE BD INSULIN SYRINGE WHEN REMOVING THE SHIELD. ADDITIONALLY, THE PLUNGER ROD WAS ALSO BROKEN. THESE EVENTS EACH OCCURRED 2 TIMES IN LOT 7306959, 2 TIMES IN LOT 9259095, 2 TIMES IN LOT 7198837, AND 2 TIMES IN LOT 6242668. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NEEDLES ARE BENDING WHEN TAKING INJECTION. STATED, SOME NEEDLES ARE BENDING WHEN INSERTING INTO VIAL. STATED, NEEDLES ARE BENT ONCE SHE REMOVES THE SHIELD, (NEW OUT OF BAG). STATED, NEEDLE HUB SEPARATED WHEN REMOVING THE SHIELD. STATED, SHIELDS DIFFICULT TO REMOVE. STATED, DOES NOT RE-USE AND WILL ROTATE SITES. STATED, SHE HAD THESE DIFFERENT ISSUES ON AND OFF FOR MONTHS."
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE BD INSULIN SYRINGE WHEN REMOVING THE SHIELD. ADDITIONALLY, THE PLUNGER ROD WAS ALSO BROKEN. THESE EVENTS EACH OCCURRED 2 TIMES IN LOT 7306959, 2 TIMES IN LOT 9259095, 2 TIMES IN LOT 7198837, AND 2 TIMES IN LOT 6242668. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NEEDLES ARE BENDING WHEN TAKING INJECTION STATED, SOME NEEDLES ARE BENDING WHEN INSERTING INTO VIAL STATED, NEEDLES ARE BENT ONCE SHE REMOVES THE SHIELD, (NEW OUT OF BAG) STATED, NEEDLE HUB SEPARATED WHEN REMOVING THE SHIELD STATED, SHIELDS DIFFICULT TO REMOVE STATED, DOES NOT RE-USE AND WILL ROTATE SITES. STATED, SHE HAD THESE DIFFERENT ISSUES ON AND OFF FOR MONTHS."
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7306959, MEDICAL DEVICE EXPIRATION DATE: 2022-10-31, DEVICE MANUFACTURE DATE: 2017-11-02. MEDICAL DEVICE LOT #: 9259095, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: 2019-09-16. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE BD INSULIN SYRINGE WHEN REMOVING THE SHIELD. THIS OCCURRED 2 TIMES IN LOT 7306959 AND 2 TIMES IN LOT 9259095. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER STATED, NEEDLES ARE BENDING WHEN TAKING INJECTION: STATED, SOME NEEDLES ARE BENDING WHEN INSERTING INTO VIAL, STATED, NEEDLES ARE BENT ONCE SHE REMOVES THE SHIELD, (NEW OUT OF BAG), STATED, NEEDLE HUB SEPARATED WHEN REMOVING THE SHIELD, STATED, SHIELDS DIFFICULT TO REMOVE, STATED, DOES NOT RE-USE AND WILL ROTATE SITES, STATED, SHE HAD THESE DIFFERENT ISSUES ON AND OFF FOR MONTHS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 934097 | BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 328466 | SEE SECTION H.10. | 00382908466035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |