BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
Report
- Report Number
- 9616066-2023-01745
- Event Type
- Malfunction
- Date Received
- August 15, 2023
- Date of Event
- August 1, 2023
- Report Date
- September 20, 2023
- Manufacturer
- SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 10885403236600
- PMA / PMN Number
- K083472
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 17-AUG-2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE MODEL MP5301-C LOT 23049109 WAS RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS ATTACHED TO A 10 ML BD SYRINGE FILLED WITH WATER. THE SET WAS UNABLE TO BE FLUSHED. FURTHER VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED EXCESS SOLVENT NEAR THE FEMALE LUER. THE CUSTOMER COMPLAINT THAT THE SET WAS UNABLE TO BE FLUSHED WAS REPLICATED. A DEVICE HISTORY RECORD REVIEW FOR MODEL MP5301-C LOT NUMBER 23049109 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A TREND FOR THIS OCCLUSION ISSUE HAS BEEN IDENTIFIED FOR THIS PRODUCT LINE. A CAPA (CORRECTIVE ACTION PREVENTATIVE ACTION) HAS BEEN INITIATED, AND A TEAM HAS BEEN ASSEMBLED IN ORDER TO INVESTIGATE THE ISSUE. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: D.4. MEDICAL DEVICE LOT #: 23049109. D.4. MEDICAL DEVICE EXPIRATION DATE: 07-APR-2026. H.4. DEVICE MANUFACTURE DATE: 06-APR-2023.
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS BLOCKED DURING THE FLUSH BEFORE BEING PLACED ON THE IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS A J-LOOP (BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLESS CONNECTOR: MP5301-C ) TURNED IN TO HER BY AN ED NURSE STATING IT WOULD NOT FLUSH -EVEN TO BE PRIMED BEFORE PLACING ON AN PIV."
IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS BLOCKED DURING THE FLUSH BEFORE BEING PLACED ON THE IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS A J-LOOP (BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLESS CONNECTOR: MP5301-C ) TURNED IN TO HER BY AN ED NURSE STATING IT WOULD NOT FLUSH -EVEN TO BE PRIMED BEFORE PLACING ON AN PIV."
IT WAS REPORTED THAT THE BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS BLOCKED DURING THE FLUSH BEFORE BEING PLACED ON THE IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS A J-LOOP (BD MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLESS CONNECTOR: MP5301-C) TURNED IN TO HER BY AN ED NURSE STATING IT WOULD NOT FLUSH -EVEN TO BE PRIMED BEFORE PLACING ON AN PIV."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 483714 | BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS, S.A. DE C.V. | 23049109 | 10885403236600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |