BD PLASTIPAK¿ SYRINGE

Report

Report Number: 3003152976-2021-00715
Event Type: Malfunction
Date Received: October 29, 2021
Date of Event: September 30, 2021
Report Date: November 11, 2021
Manufacturer: BECTON DICKINSON, S.A.
Product Code: FMF
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION: ONE PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE PICTURE RECEIVED IT CAN BE SEEN ONE SYRINGE WITH A SMALL PARTICLE EMBEDDED IN THE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 2008338, 2008339, 2010106, 2011033, 2011096, 2011105, 2011111, 1908251, 1909214, 2007101, 2012026, 2012027, 2012062 AND 2103094. NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE, INJECTION OF BURNT MATERIAL GENERATED DURING MOLDING PROCESS. H3 OTHER TEXT : SEE H.10

Description of Event or Problem · 0

IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD REPORTS OF FOREIGN MATTER ON 72 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SLADE HEALTH WOULD LIKE TO REPORT SEVERAL 50ML BD SYRINGES REPORTED DURING IN PROCESS CHECK TO HAVE BROWN COLOUR MARKINGS OR FOREIGN MATERIAL.

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1908251. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-08-05. MEDICAL DEVICE LOT #: 1909214. MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. DEVICE MANUFACTURE DATE: 2019-09-05. MEDICAL DEVICE LOT #: 2007101. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. DEVICE MANUFACTURE DATE: 2020-07-27. MEDICAL DEVICE LOT #: 2008338. MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. DEVICE MANUFACTURE DATE: 2020-08-12. MEDICAL DEVICE LOT #: 2008339. MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. DEVICE MANUFACTURE DATE: 2020-08-27. MEDICAL DEVICE LOT #: 2010106. MEDICAL DEVICE EXPIRATION DATE: 2025-09-30. DEVICE MANUFACTURE DATE: 2020-10-26. MEDICAL DEVICE LOT #: 2011033. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-11-26. MEDICAL DEVICE LOT #: 2011096. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-11-24. MEDICAL DEVICE LOT #: 2011105. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-11-25. MEDICAL DEVICE LOT #: 2011111. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2020-11-30. MEDICAL DEVICE LOT #: 2012026. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-12-21. MEDICAL DEVICE LOT #: 2012027. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-12-21. MEDICAL DEVICE LOT #: 2012062. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-11-30. MEDICAL DEVICE LOT #: 2103094. MEDICAL DEVICE EXPIRATION DATE: 2026-02-28. DEVICE MANUFACTURE DATE: 2021-03-18. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD REPORTS OF FOREIGN MATTER ON 72 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SLADE HEALTH WOULD LIKE TO REPORT SEVERAL 50ML BD SYRINGES REPORTED DURING IN PROCESS CHECK TO HAVE BROWN COLOUR MARKINGS OR FOREIGN MATERIAL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1619246	BD PLASTIPAK¿ SYRINGE	SYRINGE	FMF	BECTON DICKINSON, S.A.		SEE H.10

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown