BD MICROTAINER® CONTACT-ACTIVATED LANCET
Report
- Report Number
- 2243072-2022-00805
- Event Type
- Malfunction
- Date Received
- June 15, 2022
- Date of Event
- June 3, 2022
- Report Date
- July 13, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMK
- UDI-DI
- 00382903665938
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: A4H81N1, MEDICAL DEVICE EXPIRATION DATE: 2025-08-31, DEVICE MANUFACTURE DATE: 2020-11-02. MEDICAL DEVICE LOT #: B4A49B3, MEDICAL DEVICE EXPIRATION DATE: 2026-01-31, DEVICE MANUFACTURE DATE: 2021-03-29. MEDICAL DEVICE LOT #: B4C89F1, MEDICAL DEVICE EXPIRATION DATE: 2026-04-30, DEVICE MANUFACTURE DATE: 2021-09-21, MEDICAL DEVICE LOT #: B4D49F6, MEDICAL DEVICE EXPIRATION DATE: 2026-05-31, DEVICE MANUFACTURE DATE: 2021-08-05. IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND AS HIGH TECH HTL IS AN OEM MANUFACTURING SITE.
INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS OF EACH OF THE 6 LOT NUMBERS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES FOR BROKEN, FOREIGN MATTER, DEFECTIVE MOLDING WERE OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUES WERE OBSERVED IN CUSTOMER SAMPLES. ONLY LOT NUMBER B4D49F6 WAS ALSO CONFIRMED FOR EMBEDDED STAINS ON LANCETS IN RETENTION SAMPLES TESTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOTS RELEASED WERE MET, EXCEPT FOR LOT NUMBERS B4A49B3 (EMBEDDED STAINS, DAMAGED SHIELD) AND B4C79E7 (STAINS ON TABS). THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES BROKEN, FOREIGN MATTER AND DEFECTIVE MOLDING. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE OF FOREIGN MATTER WAS ATTRIBUTED TO TWO AREAS, INJECTION AND ASSEMBLY. INJECTION: LACK OF EFFECTIVE COLLAR AND CHUTES DIRECTING COMPONENTS STRAIGHT ON CONVEYOR TRANSPORT CAN MAKE COMPONENTS FALL DOWN DURING RELEASE FROM MOLD AFTER INJECTION AND HIT DIRT SURFACES; LEAKING COOLANT FROM THE MOLD COOLING SYSTEM AND OF OIL STAINS SURFACE OF PARTS OF THE MACHINE THAT HAVE CONTACT WITH THE COMPONENTS. AFTER SERVICE OF THE MACHINE, DIRT IS NOT REMOVED FROM THE MACHINE AREA. COMPONENTS ARE THEN STAINED FROM THE DIRTY MACHINE PARTS. ASSEMBLY: DIRTY CASSETTES ON ASSEMBLY MACHINES. DIRT COMING FROM LASER STATION WHERE THE LOT NUMBER IS BURNT BY THE LASER. THE PROCESS OF BURNING THE LOT NUMBER BY LASER GENERATE THE DUST WHICH SEDIMENT ON THE CASSETTES. THE DUST WAS NOT REMOVED BECAUSE OF UNSEALED SYSTEM OF DUST DRAIN. THE CASSETTES WERE IMPRECISELY CLEANED. REGARDING BROKEN LANCETS, PROCESS OWNER AT THE TIME OF LANCET PRODUCTION DID NOT UNDERTAKE ADEQUATE ACTIONS. THE PROBLEM WAS VISIBLE WHEN MOLD DEDICATED TO SHIELD WAS ASSEMBLED ON ONE OF THE INJECTION MACHINES, WHICH HAD SOME ISSUE WITH PLASTICIZING SYSTEM. MOLD HAS BEEN TRANSFERRED TO ANOTHER INJECTION MACHINE, DEFECT WAS THEN NOT OBSERVED. REGARDING DEFECTIVE MOLDING, AESTHETIC DISADVANTAGES RESULT FROM THE WEAR OF THE TOOL (INJECTION MOLD), THE NUMBER OF CYCLES USED SIGNIFICANTLY AFFECTS THE QUALITY OF DETAILS. MONTHLY AND QUARTERLY INSPECTIONS ARE CARRIED OUT IN ORDER TO DETECT POSSIBLE DEFECTS OR IRREGULARITIES IN THE FUNCTIONING OF THE MOLD MACHINES. ALL DETECTED IRREGULARITIES ARE REPORTED AND CORRECTED AS SOON AS THEY ARE REPORTED BY THE MACHINE OPERATOR. MONITORING THE NUMBER OF REPORTED DEFECTS (STAINS) FROM THE ASSEMBLY DEPARTMENT AND PACKAGING DEPARTMENT FOR THE OCCURRENCE OF A STAINS DEFECT PLANNED TO CONTINUE TILL END OF THE YEAR. CLEANING THE INJECTION MOLDING MACHINE LINE FOR HOUSING, CAP, INTERNAL BODY CONSISTS OF COMPREHENSIVE CLEANING OF EACH MACHINE AT INTERVALS OF UP TO 4 WEEKS. IT IS INCLUDED IN CLEANING SCHEDULE, EACH CLEANING IS CONFIRMED BY THE MACHINE LEADER. COST FOR THE PURCHASE AND INSTALLATION OF SELECTED LINES WITH COVERS IS IN THE PROCESS OF APPROVAL, EQUIPPING THE LINE WITH COVERS ALLOWS THE LINE TO BE PROPERLY KEPT CLEAN, MINIMIZING THE RISK OF CONTAMINATION FROM THE MACHINE'S SURROUNDINGS. IT IS A LONG TERM ACTION TO HELP PREVENT THE STAIN OCCURRENCE. HOWEVER, ACTIONS ALREADY IMPLEMENTED AND ONGOING ACTIONS ARE ALLOWING BD TO CONTROL THIS DEFECT AND MINIMIZE ITS OCCURRENCE AT THE CUSTOMER SITE. OUR SUPPLIER HAS CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) IN PLACE. NO ADDITIONAL CORRECTIVE ACTIONS WILL BE TAKEN SINCE THE REPORTED BATCH NUMBERS WERE MANUFACTURED BEFORE CAPA IMPLEMENTATION. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 13-JUN-2022.
IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE DEVICE EXPERIENCED MOLDING DEFECTS WITH SHARP PROTRUSIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED NON-BIOLOGICAL FMS (DIRT) ON PRODUCTS. AFFECTED LOT NUMBERS ARE AS FOLLOWS MOLDING DEFECT WITH SHARP PROTRUSSIONS: A4H81N1 ×2, B4A49B3×2, B4C89F1 ×18, B4D49F6 ×2.
IT WAS REPORTED WHEN USING THE BD MICROTAINER® CONTACT-ACTIVATED LANCET, THE DEVICE EXPERIENCED MOLDING DEFECTS WITH SHARP PROTRUSIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED NON-BIOLOGICAL FMS (DIRT) ON PRODUCTS. AFFECTED LOT NUMBERS ARE AS FOLLOWS MOLDING DEFECT WITH SHARP PROTRUSSIONS: A4H81N1 ×2 B4A49B3×2 B4C89F1 ×18 B4D49F6 ×2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2118690 | BD MICROTAINER® CONTACT-ACTIVATED LANCET | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE | FMK | BECTON DICKINSON | B4D49F6 | 00382903665938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |