BD 10ML SYRINGE LUER-LOK TIP

Report

Report Number: 1213809-2019-00576
Event Type: Malfunction
Date Received: May 30, 2019
Date of Event: May 14, 2019
Report Date: July 10, 2019
Manufacturer: BECTON DICKINSON MEDICAL SYSTEMS
Product Code: FMF
PMA / PMN Number: K980987
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION SUMMARY: 19 LOOSE 10ML SYRINGES WERE RECEIVED IN A LOOSE PLASTIC BAG AND WERE VISUALLY EVALUATED. MOST SYRINGES WERE FOUND TO HAVE A PIECE OF OPAQUE SEMI-CLEAR SCOTCH TAPE ATTACHED, WRAPPED AROUND THE BARREL. 13 SYRINGES HAD SMALLER THAN LEVEL 3 LOOSE PARTICLES UNDER THE TAPE. 3 SYRINGES HAD SLIGHTLY LARGER THAN LEVEL 3 PARTICLES UNDER THE TAPE. 2 SYRINGES HAD INK SMEARS OUTSIDE SCALE MARKINGS COVERED WITH A TAPE. THE PARTICLES OBSERVED WERE ALL OUTSIDE THE FLUID PATH ON THE OUTSIDE OF THE BARREL UNDER THE CUSTOMER¿S TAPE. THEY WERE THIN FIBERS AND OTHER SMALL PARTICULATES. 1 SYRINGE WAS FOUND TO HAVE A BROKEN THUMB REST. NO EMBEDDED FOREIGN MATTER PARTICLES WERE FOUND IN ANY OF THE SAMPLES. THE PRODUCT RECEIVED HAD BEEN MANIPULATED AND NOT IN ITS ORIGINAL CONFIGURATION, THEREFORE IT IS UNKNOWN WHERE THE SMALL PARTICLES ON THE OUTSIDE OF THE BARRELS ORIGINATED FROM. THEREFORE, BASED ON THE INFORMATION AVAILABLE TODAY, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT ORIGINATED AT THE MANUFACTURING PLANT. POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 9001917 AND 9058772 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE SECTION H.10.

Description of Event or Problem · 0

IT WAS REPORTED THAT THERE WAS FOREIGN MATTER IN DEVICE AND ONE SYRINGE WAS DAMAGED WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301029 BATCH NO. 9001917, 9058772. (3 OF 3) IT WAS REPORTED SYRINGES HAVE FOREIGN MATTER AND ONE SYRINGE HAS A BROKEN FLANGE. "DURING AN INSPECTION OF OUR INVENTORY, IT WAS DETERMINED THAT THE SYR, 10CC L/L (ITEM NUMBERS: 301029). HAD DEFECT ATTRIBUTED TO EMBEDDED PARTICULATE. ADDITIONAL EMAIL RESPONSES FROM CUSTOMER: ITEM NUMBER LOT # DATE INSPECTED SYR, 10CC L/L 301029 9001917, 9058772 , ITEM QTY DEFECTIVE SYR, 10CC L/L 21. RECEIVED EMAIL RESPONSE FROM INFORMATION REQUEST 5.16.19: Q:IT WAS NOTED ON THE ORIGINAL. ¿THE MAJORITY OF THOSE DEFECTS WERE ATTRIBUTED TO EMBEDDED PARTICULATE¿ WE HAVE CAPTURED THE FOREIGN MATTER ISSUE, BUT WERE THERE ADDITIONAL DEFECTS FOUND? IF SO, CAN YOU PLEASE PROVIDE ADDITIONAL DEFECT DETAILS FOR EACH MATERIAL NUMBER SO THAT WE MAY DOCUMENT THE COMPLAINTS. A: THE ADDITIONAL DEFECTS INCLUDE LOOSE BLACK PARTICULATE (SYR, 10CC L/L), AND 1 BROKEN SYRINGE (SYR, 10CC L/L). Q: IS IT KNOWN HOW MANY OUT OF THE 21 BELONGED TO LOT 9001917 AND HOW MANY BELONGED TO 9058772? A: I DO NOT KNOW THE QUANTITY BELONGING TO EITHER LOT. 5/20/2019 RECVD EMAIL CLARIFICATION FROM CUSTOMER STATING: I APOLOGIZE FOR ANY DELAY. I DO NOT KNOW WHICH LOT THE BROKEN 10 CC SYR, L/L, WAS FROM. THE ISSUE WAS ONE OF THE FLANGES HAD BROKEN OFF.

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 #: 9001917, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-01. MEDICAL DEVICE LOT #: 9058772, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-02-27. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN." INITIAL REPORTER PHONE #: UNKNOWN. DEVICE EVALUATED BY MFR: A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS FOREIGN MATTER IN DEVICE AND ONE SYRINGE WAS DAMAGED WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301029 BATCH NO. 9001917, 9058772. (3 OF 3). IT WAS REPORTED SYRINGES HAVE FOREIGN MATTER AND ONE SYRINGE HAS A BROKEN FLANGE. "DURING AN INSPECTION OF OUR INVENTORY, IT WAS DETERMINED THAT THE SYR, 10CC L/L (ITEM NUMBERS: 301029). HAD DEFECT ATTRIBUTED TO EMBEDDED PARTICULATE. ADDITIONAL EMAIL RESPONSES FROM CUSTOMER: ITEM, ITEM NUMBER, LOT #, DATE INSPECTED: SYR, 10CC L/L, 301029, 9001917/9058772. ITEM, QTY DEFECTIVE: SYR, 10CC L/L, 21. RECEIVED EMAIL RESPONSE FROM INFORMATION REQUEST 5.16.19: Q: IT WAS NOTED ON THE ORIGINAL. ¿THE MAJORITY OF THOSE DEFECTS WERE ATTRIBUTED TO EMBEDDED PARTICULATE¿ WE HAVE CAPTURED THE FOREIGN MATTER ISSUE, BUT WERE THERE ADDITIONAL DEFECTS FOUND? IF SO, CAN YOU PLEASE PROVIDE ADDITIONAL DEFECT DETAILS FOR EACH MATERIAL NUMBER SO THAT WE MAY DOCUMENT THE COMPLAINTS? A: THE ADDITIONAL DEFECTS INCLUDE LOOSE BLACK PARTICULATE (SYR, 10CC L/L), AND 1 BROKEN SYRINGE (SYR, 10CC L/L). Q: IS IT KNOWN HOW MANY OUT OF THE 21 BELONGED TO LOT 9001917 AND HOW MANY BELONGED TO 9058772? A: I DO NOT KNOW THE QUANTITY BELONGING TO EITHER LOT. ON 5/20/2019 RECVD EMAIL CLARIFICATION FROM CUSTOMER STATING: I APOLOGIZE FOR ANY DELAY. I DO NOT KNOW WHICH LOT THE BROKEN 10 CC SYR, L/L, WAS FROM. THE ISSUE WAS ONE OF THE FLANGES HAD BROKEN OFF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
448394	BD 10ML SYRINGE LUER-LOK TIP	PISTON SYRINGE	FMF	BECTON DICKINSON MEDICAL SYSTEMS		SEE H.10

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other