BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
Report
- Report Number
- 2243072-2019-02553
- Event Type
- Malfunction
- Date Received
- November 13, 2019
- Date of Event
- July 3, 2019
- Report Date
- December 10, 2019
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- PMA / PMN Number
- K123213
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: SITE LEGAL NAME (FDA): BECTON DICKINSON, S.A. - SAN AGUSTIN DE GUADALIX, SPAIN / 28750. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) WAS UNABLE TO CONNECT CAUSING LEAKAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE MAXPLUS CONNECTOR WAS UNABLE TO CONNECT TO THE PHASEAL CONNECTOR RESULTING IN A CHEMO SPILL. DETAIL: THE CONNECTOR DID NOT CONNECT AND CAUSED CHEMO SPILL. NUMBER OF OCCURRENCES: 1. D.1. MEDICAL DEVICE BRAND NAME: BD PHASEAL¿ CONNECTOR LUER LOCK (C35). D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. D.3. MEDICAL DEVICE MANUFACTURER: SAN AGUSTIN. D.2. MEDICAL DEVICE CATALOG #: 515200. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-10-31. D.4. MEDICAL DEVICE LOT #: 1811106. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: SAN AGUSTIN. G.5. PMA/510(K)#: K123213. H.4. DEVICE MANUFACTURE DATE: 2018-12-04.
CORRECTION: THIS COMPLAINT WILL BE CANCELLED. PRODUCT WAS RECEIVED ALONG WITH SAMPLES THAT BELONG TO AN EXISTING INVESTIGATION SUPPORTED BY THE SAN DIEGO TEAM. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER REQUESTING IF THERE WAS A FAILURE WITH THE CONNECTOR THAT WAS RETURNED, NO RESPONSE HAS BEEN RECEIVED. AS THERE IS NO REPORTED FAILURE RELATED TO THE DEVICE, THIS RECORD WILL BE CANCELLED.
IT WAS REPORTED THAT BD PHASEAL¿ CONNECTOR LUER LOCK (C35) WAS UNABLE TO CONNECT CAUSING LEAKAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE MAXPLUS CONNECTOR WAS UNABLE TO CONNECT TO THE PHASEAL CONNECTOR RESULTING IN A CHEMO SPILL. DETAIL: THE CONNECTOR DID NOT CONNECT AND CAUSED CHEMO SPILL. NUMBER OF OCCURRENCES: 1.
IT WAS REPORTED THAT UNSPECIFIED BD¿ CONNECTOR WAS UNABLE TO CONNECT CAUSING LEAKAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE MAXPLUS CONNECTOR WAS UNABLE TO CONNECT TO THE PHASEAL CONNECTOR RESULTING IN A CHEMO SPILL.
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(4) USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT UNSPECIFIED BD¿ CONNECTOR WAS UNABLE TO CONNECT CAUSING LEAKAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE MAXPLUS CONNECTOR WAS UNABLE TO CONNECT TO THE PHASEAL CONNECTOR RESULTING IN A CHEMO SPILL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1108265 | BD PHASEAL¿ CONNECTOR LUER LOCK (C35) | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | 1811106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |