BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM
Report
- Report Number
- 2243072-2022-01022
- Event Type
- Malfunction
- Date Received
- July 29, 2022
- Date of Event
- June 28, 2022
- Report Date
- October 12, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- LHI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS YUKON. THIS SITE IS AN OEM MANUFACTURING SITE. 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. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: A MV0413-0006 SAMPLE WAS NOT RETURNED FOR INVESTIGATION, FURTHERMORE THE LOT NUMBER WAS NOT AVAILABLE TO ASSIST THE INVESTIGATION; HOWEVER THE CUSTOMER DID PROVIDE A USED MEDICATION VIAL. THE FEEDBACK PROVIDED BY THE CUSTOMER INDICATES THAT THE CUSTOMER FACED DIFFICULTIES IN ACCESSING THE VIAL, WHICH RESULTED IN AN OCCLUSION. AS PART OF THE FEEDBACK, THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE; ANALYSIS OF WHICH NOTED THAT THE SPIKE OF THE VIAL ACCESS DEVICE HAD ONLY PARTIALLY PENETRATED THE RUBBER STOPPER OF THE VIAL. A VISUAL INSPECTION OF THE RETURNED VIAL INDICATES THAT THE VIAL SEPTUM APPEARS TO HAVE BEEN PIECED ON THE EDGE OF THE CENTRAL CIRCLE OF THE RUBBER BUNG. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE MV0413-0006 SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. THE SPIKE OF THE MV0420-0006 VIAL ACCESS DEVICE IS DESIGNED TO BE INSERTED AT THE CENTRAL CIRCLE ON THE RUBBER BUNG OF THE VIAL USING A VERTICAL FORCE AND NOT BY USING AN ANGLED INSERTION TECHNIQUE. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT.
IT WAS REPORTED WHILE USING BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM THE STOPPER DISLODGED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ADAPTER CANNOT BE PIERCED THROUGH THE RUBBER. THE TIP OF THE ADAPTER DOES NOT REACH THROUGH THE RUBBER, SO NO LIQUID CAN BE TAKEN OUT. ACCORDING TO THE CUSTOMER, THE RUBBER MEMBRANE CURVES DOWNWARDS A LOT WHEN IT IS PIERCED, AND IT PUSHES THE RUBBER DOWN TOO FAR FOR THE MANDREL TO COME OUT. THE CUSTOMER STABS IN THE MIDDLE, WITH A SLIGHT TWISTING MOTION, AND HAS EXPLICITLY MADE SURE THAT THE ALUMINIUM RING IS NOT TOUCHED!
IT WAS REPORTED WHILE USING BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM THE STOPPER DISLODGED INTO THE VIAL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ADAPTER CANNOT BE PIERCED THROUGH THE RUBBER. THE TIP OF THE ADAPTER DOES NOT REACH THROUGH THE RUBBER, SO NO LIQUID CAN BE TAKEN OUT. ACCORDING TO THE CUSTOMER, THE RUBBER MEMBRANE CURVES DOWNWARDS A LOT WHEN IT IS PIERCED, AND IT PUSHES THE RUBBER DOWN TOO FAR FOR THE MANDREL TO COME OUT. THE CUSTOMER STABS IN THE MIDDLE, WITH A SLIGHT TWISTING MOTION, AND HAS EXPLICITLY MADE SURE THAT THE ALUMINIUM RING IS NOT TOUCHED!
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719274 | BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 13 MM | SET, IV FLUID TRANSFER | LHI | BECTON DICKINSON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |