BD PHASEAL¿ INFUSION ADAPTER C100
Report
- Report Number
- 3003152976-2021-00743
- Event Type
- Malfunction
- Date Received
- November 8, 2021
- Date of Event
- October 11, 2021
- Report Date
- December 13, 2021
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- UDI-DI
- 00382905153068
- PMA / PMN Number
- K123213
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2011204 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. LEAK TESTING IS PERFORMED ON ALL BATCHES DURING MANUFACTURING TO ENSURE MEMBRANE QUALITY. FIVE RETAINED SAMPLES FROM LOT 2011204 WERE EVALUATED AND NO DEFECTS OR DAMAGE TO THE INFUSION ADAPTERS WERE FOUND. BASED ON OUR QUALITY TEAM'S INVESTIGATION, THE LEAK CANNOT BE DETERMINED WHERE IT ORIGINATED FROM AS NO FURTHER INFORMATION IS AVAILABLE ON THE DEFECTIVE SAMPLE NO ISSUES RELATED TO THE C100 INFUSION ADAPTER CAN BE IDENTIFIED. PRODUCT UNDERGOES A SERIES OF INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING FLOW RATE VERIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H.10.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE BD PHASEAL¿ INFUSION ADAPTER C100, THE DEVICE EXPERIENCED LEAKAGE AROUND THE INFUSION ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 1 GEMCITABINE BAG WAS LEAKING FROM THE PHASEAL ADAPTER ATTACHMENT. DUE TO SAFETY CONCERNS, THE CUSTOMER IMMEDIATELY DISCARDED THE AFFECTED PRODUCT AND DID NOT TAKE ANY PHOTOGRAPHS. FURTHER INFORMATION REQUESTED FROM CUSTOMER VIA QA SPECIALIST OF BAXTER COMPOUNDING SERVICES REGARDING WHETHER THERE WAS ANY OBVIOUS DAMAGE IDENTIFIED ON THE PHASEAL ADAPTER, TO THE PRODUCT PACKAGING, OR THE CARTON THE PRODUCT WAS RECEIVED IN. THIS WAS IDENTIFIED AT THE HOSPITAL ON (B)(6) 2021 PRIOR TO USE. THE ACTUAL SAMPLE WAS DISCARDED BY THE CUSTOMER, NO PHOTOGRAPHS HAVE BEEN PROVIDED FOR INVESTIGATION. BAXTER COMPOUNDING SERVICES PRODUCT: GEMCITABINE LIQUID (DBL) 1552.5MG IN SODIUM CHLORIDE 0.9% VIAFLEX BAG.
IT WAS REPORTED WHEN USING THE BD PHASEAL¿ INFUSION ADAPTER C100, THE DEVICE EXPERIENCED LEAKAGE AROUND THE INFUSION ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: 1 GEMCITABINE BAG WAS LEAKING FROM THE PHASEAL ADAPTER ATTACHMENT. DUE TO SAFETY CONCERNS, THE CUSTOMER IMMEDIATELY DISCARDED THE AFFECTED PRODUCT AND DID NOT TAKE ANY PHOTOGRAPHS. FURTHER INFORMATION REQUESTED FROM CUSTOMER VIA QA SPECIALIST OF BAXTER COMPOUNDING SERVICES REGARDING WHETHER THERE WAS ANY OBVIOUS DAMAGE IDENTIFIED ON THE PHASEAL ADAPTER, TO THE PRODUCT PACKAGING, OR THE CARTON THE PRODUCT WAS RECEIVED IN. THIS WAS IDENTIFIED AT THE HOSPITAL ON (B)(6) 2021 PRIOR TO USE. THE ACTUAL SAMPLE WAS DISCARDED BY THE CUSTOMER, NO PHOTOGRAPHS HAVE BEEN PROVIDED FOR INVESTIGATION. BAXTER COMPOUNDING SERVICES PRODUCT: GEMCITABINE LIQUID (DBL) 1552.5MG IN SODIUM CHLORIDE 0.9% VIAFLEX BAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1666794 | BD PHASEAL¿ INFUSION ADAPTER C100 | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | 515306 | 2011204 | 00382905153068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |