BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY
Report
- Report Number
- 1213809-2022-00085
- Event Type
- Malfunction
- Date Received
- February 18, 2022
- Date of Event
- February 8, 2022
- Report Date
- March 17, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- PMA / PMN Number
- K980987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. LOT NUMBER WAS NOT REPORTED; HOWEVER, POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THOSE NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1111285 . MEDICAL DEVICE EXPIRATION DATE: MAR 31 2026. DEVICE MANUFACTURE DATE: APR 30 2021. MEDICAL DEVICE LOT #: 1152292. MEDICAL DEVICE EXPIRATION DATE: MAY 31 2026. DEVICE MANUFACTURE DATE: JUNE 30 2021. MEDICAL DEVICE LOT #: 1111296. MEDICAL DEVICE EXPIRATION DATE: APR 30 2026. DEVICE MANUFACTURE DATE: MAY 27 2021. MEDICAL DEVICE LOT #: 1239987. MEDICAL DEVICE EXPIRATION DATE: AUG 31 2026. DEVICE MANUFACTURE DATE: SEPT 9 2021. MEDICAL DEVICE LOT #: 1270083. MEDICAL DEVICE EXPIRATION DATE: AUG 31 2026. DEVICE MANUFACTURE DATE: OCT 1 2021. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 3/1/2022. H.6. INVESTIGATION: FIVE 10 ML SYRINGES (P/N 301029) WERE RECEIVED. ALL THE SYRINGES WERE LOOSE AND ONE HAD THE PLUNGER ROD SEPARATED FROM THE BARREL. ONE SYRINGE WAS MISSING PRINT FROM THE 8ML TO THE 9.6ML GRAD LINES AND HAD INK DOTS ON THE OPPOSITE SIDE OF THE GRAD LINES. ONE SYRINGE HAD TWELVE INK DOTS. ONE SYRINGE HAD A VERTICAL CRACK ON BARREL AND LOOSE PLUNGER ROD. ONE SYRINGE HAD HALF OF ONE RIB ON THE PLUNGER ROD MISSING AND WAS PARTIALLY MISSING THE THUMB REST. THE LAST SYRINGE HAD A TWO VERTICAL CRACK. THE CONDITIONS OBSERVED WERE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SCALE MARKING DEFECTS IS ASSOCIATED WITH THE PRINTING PROCESS AND POTENTIAL ROOT CAUSE FOR THE DAMAGED COMPONENTS IS ASSOCIATED WITH THE ASSEMBLY PROCESS. BATCHES 1111285, 1152292, 1111296, 1239987 AND 1270083 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 PROVIDED BATCH NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED WHILE USING BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY THREE SYRINGES WERE FOUND TO BE DEFORMED AND BROKEN, ONE SYRINGE HAD FOREIGN MATTER CONTAMINATING THE FLUID PATHWAY, AND ONE SYRINGE HAD UNCLEAR SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL 301029 BATCH UNKNOWN ( POSSIBLE LOT 1111285, 1152292, 1111296, 1239987, 1270083). 1 SYRINGE BAD PRINT, 1 SYRINGE INK CONTAMINATION, 3 SYRINGES DEFORMED AND BROKEN.
IT WAS REPORTED WHILE USING BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY THREE SYRINGES WERE FOUND TO BE DEFORMED AND BROKEN, ONE SYRINGE HAD FOREIGN MATTER CONTAMINATING THE FLUID PATHWAY, AND ONE SYRINGE HAD UNCLEAR SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL 301029 BATCH UNKNOWN ( POSSIBLE LOT 1111285, 1152292, 1111296, 1239987, 1270083). 1 SYRINGE BAD PRINT, 1 SYRINGE INK CONTAMINATION, 3 SYRINGES DEFORMED AND BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3551 | BD LUER-LOK¿ 10 ML BULK PACK LUER LOCK TIP WITHOUT SAFETY | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |