MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE, 1 ML; PISTON SYRINGE

Catalog Number 309648

Device Problems Volume Accuracy Problem (1675); Defective Component (2292); Defective Device (2588)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

It was reported that 2 bd luer-lok syringe, 1 ml were damaged but still operable, 4 had scale marking issues, and 2 had loose plungers.The following information was provided by the initial reporter: "2 deformed, 4 incomplete scale, 2 loose plungers ".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1083799.Medical device expiration date: 2026-02-28.Device manufacture date: 2021-03-24.Medical device lot #: 1127514.Medical device expiration date: 2026-04-30.Device manufacture date: 2021-05-07.Medical device lot #: 1146696.Medical device expiration date: 2026-05-31.Device manufacture date: 2021-05-26.

Event Description

It was reported that 2 bd luer-lok syringe, 1 ml were damaged but still operable, 4 had scale marking issues, and 2 had loose plungers.The following information was provided by the initial reporter: "2 deformed, 4 incomplete scale, 2 loose plungers.".

Manufacturer Narrative

H6: investigation summary seventy-eight loose 1ml luer-lock syringes (p/n 309648) were received.The samples were visually evaluated.Four were found to be missing the plunger components.Two were severely damaged and mangled.Excessive silicone was found on five samples.Illegible scale markings were noted on two samples.Sixty-three samples were found to have embedded foreign matter that appeared to be degraded plastic from the molding process.Six samples were acceptable 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 causes for the damaged syringe and missing components are associated with the assembly process.Potential root cause for the missing print defects is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batches #0059908, #1083799, #1127514, and #1146696 are considered in compliance with our product specification requirements for the noted defects.The excessive silicone defect is a known issue for batch #1127514.Please note that silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.A device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers 0059908, 1127514, 1146696 that could have contributed to the reported defect.Print defects were noted during manufacture of batch 1083799.H3 other text : see h10.

• Brand Name: BD LUER-LOK SYRINGE, 1 ML
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13261258
• MDR Text Key: 285412348
• Report Number: 1213809-2021-00868
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K941562
• 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: 02/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309648
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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