BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM
Report
- Report Number
- 2243072-2022-00486
- Event Type
- Malfunction
- Date Received
- April 18, 2022
- Date of Event
- March 24, 2022
- Report Date
- May 20, 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 (B)(4). 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL? YES. D9: RETURNED TO MANUFACTURER ON: 20-APR-2022. H6: INVESTIGATION SUMMARY: ONE MV0420-0006 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION HOWEVER THE CUSTOMER CONFIRMED THE REPORTED SAMPLE WAS FROM LOT 212049. THE SAMPLE WAS RECEIVED ATTACHED TO A MEDICATION VIAL CONTAINING HERCEPTIN. A VISUAL INSPECTION OF THE VIAL CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE RUBBER SEPTUM VISIBLY SEPARATED AT THE BASE OF THE VIAL. A CLOSER INSPECTION OF THE SEPTUM APPEARS TO INDICATE THAT THE VIAL HAD BEEN ATTEMPTED TO BE ACCESSED OUTSIDE OF THE TARGET PIERCING AREA OF THE VIAL. ADDITIONALLY AFTER CAREFULLY REMOVING THE VIAL ACCESS DEVICE FROM THE VIAL, THERE WAS FOUND TO BE AN OBSERVABLE DENT IN THE RIM OF THE VIAL INDICATING A POSSIBLE ERROR IN ACCESSING THE MEDICATION VIAL HOWEVER THERE WAS NO OBSERVABLE DAMAGE TO THE VIAL ACCESS DEVICE. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 212049 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A DEFINITIVE ROOT CAUSE FOR THE SEPTUM BEING PUSHED INTO THE VIAL COULD NOT BE DETERMINED, HOWEVER PREVIOUS INVESTIGATIONS HAVE REPLICATED THIS FAILURE MODE IF THE VIAL SEPTUM IS PIERCED OFF-CENTER OF THE TARGET PIERCING AREA. THE SPIKE OF THE VENTED VIAL ADAPTOR DEVICE IS INTENDED TO BE INSERTED AT THE CENTRAL CIRCLE POSITION OF THE VIAL'S SEPTUM USING A VERTICAL FORCE
IT WAS REPORTED THAT THE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM EXPERIENCED THE RUBBER STOPPER BEING DISLODGED INTO THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PUTTING THE ADAPTER ON THE BOTTLE, IT PRESSED THE RUBBER STOPPER INTO THE MEDICINE BOTTLE. ADAPTER WAS PUSHED ON STRAIGHT, IN THE MIDDLE, WITH A SLIGHT TWISTING MOTION. PATIENT INJURY? NO. TREATMENT REQUIRED? NO. USER INJURY? NO. TREATMENT REQUIRED? NO.
IT WAS REPORTED THAT THE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM EXPERIENCED THE RUBBER STOPPER BEING DISLODGED INTO THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PUTTING THE ADAPTER ON THE BOTTLE, IT PRESSED THE RUBBER STOPPER INTO THE MEDICINE BOTTLE. ADAPTER WAS PUSHED ON STRAIGHT, IN THE MIDDLE, WITH A SLIGHT TWISTING MOTION. PATIENT INJURY? NO. TREATMENT REQUIRED? NO. USER INJURY? NO. TREATMENT REQUIRED? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 867328 | BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE, 20 MM | SET, IV FLUID TRANSFER | LHI | BECTON DICKINSON | 212049 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |