MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE; PISTON SYRINGE

Model Number 309646

Device Problems Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

It was reported that 7 bd luer-lok¿ sterile, single use syringes had black foreign matter found in them, and 5 syringes had defective/missing scale markings.The following information was provided by the initial reporter, translated from (b)(6) to english: "the following issues were reported for syringe (309646): (1)foreign matter ×7: black spot(s) or dirt was found.(2)marking issue×5: defective marking was found.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 0307927.D4: medical device expiration date: 2025-10-31.H4: device manufacture date: 2020-11-02.D10: device available for eval yes, d10: returned to manufacturer on: 2021-11-29.H6: investigation summary.Five photos and twelve 5ml syringes (p/n 309646) were received, two of which were sealed in blisterpaks from batch #0307927.The samples were visually evaluated.Four of the samples were observed to have embedded black and brown foreign matter dots present sporadically along the barrel.The embedded foreign matter appeared to be degraded plastic from the molding process.The barrels were non-conforming per product specification.Five syringes were observed to have various areas of the printed scale with the ink scraped off.However, of the ink scraped off, none resulted in several individual graduation line or printed item being more than 50% missing which is the criteria for missing print categorization per product specification requirements.Two syringes were observed to have at least six ink dots of various sizes spiraling around the barrel which was non-conforming per product specification.One syringe had an ink dot on the edge of the flange which was non-conforming per product specification.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Potential root cause for the ink dot defect is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #0307927 is 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 lot number that could have contributed to the reported defect.

Event Description

It was reported that 7 bd luer-lok¿ sterile, single use syringes had black foreign matter found in them, and 5 syringes had defective/missing scale markings.The following information was provided by the initial reporter, translated from japanese to english: "the following issues were reported for syringe (309646): (1)foreign matter ×7: black spot(s) or dirt was found.(2)marking issue×5: defective marking was found.".

• Brand Name: BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12771026
• MDR Text Key: 285071336
• Report Number: 1213809-2021-00754
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: 30382903096467
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309646
• Device Catalogue Number: 309646
• Device Lot Number: 0307927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1