BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE
Report
- Report Number
- 2243072-2022-00712
- Event Type
- Malfunction
- Date Received
- May 20, 2022
- Date of Event
- May 4, 2022
- Report Date
- May 30, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- 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. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 202043 WAS PROVIDED BY THE INITIAL REPORTER. DEVICE EXPIRATION DATE: UNKNOWN. 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. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 202043. D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 18-MAY-2022. H.6. INVESTIGATION: ONE MV0413-0006 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THE REPORTED SAMPLE WAS FROM LOT 202043. THE SAMPLE WAS RECEIVED ATTACHED TO A FULL MEDICATION VIAL CONTAINING PACLITAXEL. A VISUAL INSPECTION OF THE VIAL CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE RUBBER SEPTUM VISIBLY SEPARATED FROM THE TOP OF THE VIAL. 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. ADDITIONALLY, A CLOSER INSPECTION OF THE RUBBER STOPPER APPEARS TO INDICATE THAT THE VIAL HAD BEEN ATTEMPTED TO BE ACCESSED OUTSIDE OF THE TARGET PIERCING AREA OF THE VIAL. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202043 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. PLEASE NOTE THAT 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. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT THE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PLACING THE SMART SITE ADAPTER ON THE ZIRABEV BOTTLE, THE RUBBER STOPPER COULD NOT BE PIERCED PROPERLY AND THE LIQUID COULD NOT BE DRAWN UP. THE ADAPTER WAS CENTERED, WITH A SLIGHT TWISTING MOTION.
IT WAS REPORTED THAT THE BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PLACING THE SMART SITE ADAPTER ON THE ZIRABEV BOTTLE, THE RUBBER STOPPER COULD NOT BE PIERCED PROPERLY AND THE LIQUID COULD NOT BE DRAWN UP. THE ADAPTER WAS CENTERED, WITH A SLIGHT TWISTING MOTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2319635 | BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON | 202043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |