BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR
Report
- Report Number
- 2243072-2022-02262
- Event Type
- Malfunction
- Date Received
- January 3, 2023
- Date of Event
- December 13, 2022
- Report Date
- February 27, 2023
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- UDI-DI
- 20885403236652
- PMA / PMN Number
- K051499
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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. (B)(4).
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR IS NOT ALLOWING FLUID TO COME THROUGH AND LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOT ALLOWING FOR FLUID TO COME THROUGH, AND LEAKING D1: MEDICAL DEVICE BRAND NAME: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR D4: UDI # (B)(4). D4: CATALOG # MP5303-C. D4: MEDICAL DEVICE LOT #: 22109063. D4: MEDICAL DEVICE EXPIRATION DATE: 05-OCT-2025. H4: DEVICE MANUFACTURE DATE: 04-OCT-2022. G.5. PMA / 510(K)#: K051499. D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 24-FEB-2023. INVESTIGATION SUMMARY: THREE SAMPLES (MODEL #MP5303-C, LOT 22109063) WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED BY THE CUSTOMER THAT SET IS FALLING OFF THE IV, NOT ALLOWING FLUID TO COME THROUGH AND LEAKING. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SAMPLES WERE CONNECTED TO A 10ML BD SYRINGE THEN ATTEMPTED TO BE FLUSHED WITH WATER. WHILE ATTEMPTING TO BE FLUSHED, THE SETS WERE STILL SECURELY ATTACHED TO THE SYRINGE AND NO LEAKS WERE OBSERVED. THE SETS DID NOT FALL OFF THE SYRINGE. THE SETS WERE THEN EACH ATTACHED TO A BD PRIMARY SET AND ATTEMPTED TO BE PRIMED WITH SALINE. DURING PRIMING THE SETS CONTINUED TO STAY ATTACHED TO THE PRIMARY SET AND NEVER FELL OFF. NO LEAKS WERE OBSERVED. THE FAILURE WAS UNABLE TO BE REPLICATED, AND THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOR MODEL MP5303-C LOT NUMBER 22109063 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A ROOT CAUSE FOR THE REPORTED FAILURE WAS NOT ESTABLISHED BECAUSE THE FAILURE COULD NOT BE REPLICATED. A REVIEW OF THE MALE LUER CONNECTOR HAS DETERMINED THAT IT IS CONSTRUCTED WITHIN ITS DESIGN PARAMETERS.
IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET IS NOT ALLOWING FLUID TO COME THROUGH AND LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOT ALLOWING FOR FLUID TO COME THROUGH, AND LEAKING.
IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR IS NOT ALLOWING FLUID TO COME THROUGH AND LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOT ALLOWING FOR FLUID TO COME THROUGH, AND LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523391 | BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH REMOVABLE NEEDLELESS CONNECTOR | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON | 22109063 | 20885403236652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |