UNSPECIFIED BD INFUSION SET

Report

Report Number: 2243072-2022-02261
Event Type: Malfunction
Date Received: January 2, 2023
Date of Event: December 13, 2022
Report Date: April 17, 2023
Manufacturer: BECTON DICKINSON
Product Code: FPA
PMA / PMN Number: UNKNOWN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS WERE UPDATED DUE POSSIBLE LOTS: D4: MEDICAL DEVICE LOT #: 22075907 . D4: MEDICAL DEVICE EXPIRATION DATE: 02AUG2025. H4: DEVICE MANUFACTURE DATE: 02AUG2022. D4: MEDICAL DEVICE LOT #: 22076014. D4: MEDICAL DEVICE EXPIRATION DATE: 03AUG2025. H4: DEVICE MANUFACTURE DATE: 03AUG2022. D4: MEDICAL DEVICE LOT #: 22085032. D4: MEDICAL DEVICE EXPIRATION DATE: 03AUG2025. H4: DEVICE MANUFACTURE DATE: 03AUG2022. D4: MEDICAL DEVICE LOT #: 22085073. D4: MEDICAL DEVICE EXPIRATION DATE: 10AUG2025. H4: DEVICE MANUFACTURE DATE: 10AUG2022. D4: MEDICAL DEVICE LOT #: 22085074. D4: MEDICAL DEVICE EXPIRATION DATE: 11AUG2025. H4: DEVICE MANUFACTURE DATE: 11AUG2022. D4: MEDICAL DEVICE LOT #: 22085416. D4: MEDICAL DEVICE EXPIRATION DATE: 10AUG2025. H4: DEVICE MANUFACTURE DATE: 10AUG2022. . D4: MEDICAL DEVICE LOT #: 22085436. D4: MEDICAL DEVICE EXPIRATION DATE: 11AUG2025. H4: DEVICE MANUFACTURE DATE: 11AUG2022. D4: MEDICAL DEVICE LOT #: 22085438. D4: MEDICAL DEVICE EXPIRATION DATE: 10AUG2025. H4: DEVICE MANUFACTURE DATE: 10AUG2022 THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: H6: INVESTIGATION SUMMARY IT WAS OBSERVED DURING FUNCTIONAL TESTING ON RETURNED SET MODEL 2420-0007 LOT UNKNOWN THAT A BACKFLOW WAS OBSERVED. A QUALITY NOTIFICATION WAS SENT TO THE SUPPLIER, AND THE FAILED BACK CHECK VALVE WAS SENT FOR FURTHER INVESTIGATION. FOR THE SUPPLIER INVESTIGATION, PARTICULATE PRESENCE COULD NOT BE CONFIRMED. THE CHECK VALVE WAS INSPECTED FOR BACKFLOW ON BENCH TESTERS AND BACKFLOW FAILURE WAS NOT OBSERVED. GIVEN THE FINDINGS, THE SUPPLIER IS UNABLE TO CONFIRM THE REPORTED FAILURE MODE OF BACKFLOW AND WILL CLOSE WITH NO FURTHER ACTIONS. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. A LOT IS UNKNOWN, HOWEVER, POSSIBLE LOTS WERE IDENTIFIED TO BE: 22075907, 22076014, 22085032, 22085073, 22085074, 22085416, 22085436, 22085438. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22075907 WAS PERFORMED. THERE WAS A QUALITY NOTIFICATION ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET FOR THE LOT 22075907 AS NOTIFICATION ID #200335547 ON 04AUG2022. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22076014 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22085032 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22085073 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22085074 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22085416 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22085436 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22085438 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. H3 OTHER TEXT : SEE H10.

Additional Manufacturer Narrative · 0

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATION: 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. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE (B)(6) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET EXPERIENCED OVER-INFUSION WITH THE SECONDARY MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS A REPORTED OVER-INFUSION WITH A SECONDARY MEDICATION. CLINICAL STAFF WERE ABLE TO CONFIRM BASED ON THE COLOUR OF THE PRIMARY FLUID THAT BACK-FLOW OF SECONDARY INTO THE PRIMARY DID NOT OCCUR.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET EXPERIENCED OVER-INFUSION WITH THE SECONDARY MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS A REPORTED OVER-INFUSION WITH A SECONDARY MEDICATION. CLINICAL STAFF WERE ABLE TO CONFIRM BASED ON THE COLOUR OF THE PRIMARY FLUID THAT BACK-FLOW OF SECONDARY INTO THE PRIMARY DID NOT OCCUR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2304676	UNSPECIFIED BD INFUSION SET	INTRAVASCULAR ADMINISTRATION SET	FPA	BECTON DICKINSON		SEE H10

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown