BD PHASEAL¿ INFUSION SET (C61)
Report
- Report Number
- 2243072-2019-00700
- Event Type
- Malfunction
- Date Received
- April 10, 2019
- Date of Event
- March 22, 2019
- Report Date
- June 10, 2019
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- UDI-DI
- 00382905153020
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 1007653, D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, H.4. DEVICE MANUFACTURE DATE: 2018-05-16; D.4. MEDICAL DEVICE LOT #: 1011186, D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30, H.4. DEVICE MANUFACTURE DATE: 2019-01-31; D.4. MEDICAL DEVICE LOT #: 1008839, D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, H.4. DEVICE MANUFACTURE DATE: 2019-01-31; D.4. MEDICAL DEVICE LOT #: 1007963, D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, H.4. DEVICE MANUFACTURE DATE: 2018-08-12.
INVESTIGATION: DHR REVIEW WAS DONE AND NO ISSUES WERE REPORTED DURING PRODUCTION OF THESE LOTS. 30 SAMPLES RECEIVED FOR THIS COMPLAINT 10 FROM LOT: 1011186 AND 20 ON LOT: 1011464 ALL SAMPLES WERE RECEIVED IN ORIGINAL PACKAGING. ALL 30 SAMPLES WERE TESTED FOR LEAKAGE AND ONLY ONE SAMPLE WAS LEAKING FROM LOT 1011464 ON SPIKE-TUBE JOINT. CT SCAN WAS DONE ON LEAKING SAMPLE WHICH WAS SEGREGATED DURING PRODUCTION. AFTER THIS SCAN ADDITIONAL TESTS WERE DONE ON SPIKE COMPONENT AND CONCENTRICTY OF LOWER PART OF SPIKE COMPONENT WHICH CAUSED MOLDING DEFICIT ON ONE SIDE OF COMPONENT. CAPA#891423 WAS INITIATED.
IT WAS REPORTED THAT A BD PHASEAL¿ INFUSION SET (C61) HAD LEAKAGE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PROBLEM IS STILL THERE!! THERE HAVE NOW BEEN SEVERAL INFUSIONS WHICH LEAKED DURING ADMINISTRATION, EVERYTHING CONTAMINATED, NURSING STAFF + PATIENT INVOLVED. YOU CAN SEE VERY WELL THAT THE TUBING IS NOT TIGHT AND DRIPS. NEED URGENTLY A SOLUTION! PATIENTS AND CAREGIVERS INVOLVED AS IT DRIPPED ON ADMINISTRATION. NAME OF DRUGS: PACLITAXEL ."
IT WAS REPORTED THAT A BD PHASEAL¿ INFUSION SET (C61) HAD LEAKAGE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PROBLEM IS STILL THERE!! THERE HAVE NOW BEEN SEVERAL INFUSIONS WHICH LEAKED DURING ADMINISTRATION, EVERYTHING CONTAMINATED, NURSING STAFF + PATIENT INVOLVED. YOU CAN SEE VERY WELL THAT THE TUBING IS NOT TIGHT AND DRIPS. NEED URGENTLY A SOLUTION! PATIENTS AND CAREGIVERS INVOLVED AS IT DRIPPED ON ADMINISTRATION. NAME OF DRUGS: PACLITAXEL ."
DATE OF EVENT: UNKNOWN. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT A BD PHASEAL¿ INFUSION SET (C61) HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PROBLEM IS STILL THERE!! THERE HAVE NOW BEEN SEVERAL INFUSIONS WHICH LEAKED DURING ADMINISTRATION, EVERYTHING CONTAMINATED, NURSING STAFF + PATIENT INVOLVED. YOU CAN SEE VERY WELL THAT THE TUBING IS NOT TIGHT AND DRIPS. NEED URGENTLY A SOLUTION! PATIENTS AND CAREGIVERS INVOLVED AS IT DRIPPED ON ADMINISTRATION. NAME OF DRUGS: PACLITAXEL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293997 | BD PHASEAL¿ INFUSION SET (C61) | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON | 1007653 | 00382905153020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |