BD INSULIN¿ SYRINGE
Report
- Report Number
- 1920898-2018-00721
- Event Type
- Malfunction
- Date Received
- September 19, 2018
- Date of Event
- August 28, 2018
- Report Date
- November 29, 2018
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00681131138376
- PMA / PMN Number
- K024112
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- 003
Narratives
INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7093620. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200692727] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER IN SYRINGE ON LOT # 7093620. BASED ON THE SAMPLES / PHOTO(S) 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.
INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) 1/2CC, 6MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 7093620. CUSTOMER STATES THAT SHE PUSHES ON PLUNGER AND A CLEAR LIQUID APPEARS ON THE TIP OF THE NEEDLE, STATED LIQUID COMING FROM INSIDE SYRINGE. ALL RETURNED SYRINGES WERE TESTED AND A SMALL, CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA OF 2 OUT OF 4 SYRINGES. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. WHEN THE PLUNGER IS FULLY DEPRESSED, THE SILICONE GETS DISTRIBUTED ALONG THE BARREL ROOF AND WALLS, ENSURING A LUBRICATED SURFACE FOR THE PLUNGER TO MOVE AGAINST. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. CAPA # 56537 AND SITUATION ANALYSIS # BDDC-16-871-SA HAVE BEEN OPENED TO ADDRESS THIS ISSUE. SAMPLES WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) ON 09NOV2018 FOR FURTHER REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7093620. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200692727] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSES FOR EXCESS SILICONE INCLUDE: THE FIRST IS THAT SOME ASSOCIATES DO NOT DEGAS THE SILICONE AFTER REFILLING THE TANKS. SECOND, THE SILICONE VOLUME ON THE PUMP IS A PARAMETER THAT IS BEING ADJUSTED, BUT IS NOT UNDERSTOOD AND COULD BE A POTENTIAL KPIV.
IT WAS REPORTED THAT A BD INSULIN¿ SYRINGE FORMED CLEAR LIQUID ON THE TIP OF THE NEEDLE WHEN PUSHING ON THE PLUNGER BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT A BD INSULIN¿ SYRINGE FORMED CLEAR LIQUID ON THE TIP OF THE NEEDLE WHEN PUSHING ON THE PLUNGER BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: N/A. 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 A BD INSULIN¿ SYRINGE FORMED CLEAR LIQUID ON THE TIP OF THE NEEDLE WHEN PUSHING ON THE PLUNGER BEFORE USE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729346 | BD INSULIN¿ SYRINGE | INSULIN SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 7093620 | 00681131138376 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |