MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LL BNS; PISTON SYRINGE

Catalog Number 309648

Device Problems Break (1069); Fitting Problem (2183); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: eighty-eight loose 1ml luer-lock syringes (p/n 309648) were received.The samples were visually evaluated.Sixty-two samples were observed to have an embedded brown foreign matter present on various areas of the syringes.The embedded foreign matter appeared to be degraded plastic.Ten samples were observed to have their plunger rods missing.Seven samples appeared to have been incorrectly assembled resulting in severely jammed or distorted stoppers.Nine samples were severely mangled or broken to the point of not being usable.All defects observed were non-conforming per product specification.Furthermore, 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.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: 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 damage, missing plunger rods, and jammed/distorted stoppers is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batches 0059908 and 9294872 are considered in compliance with our product specification requirements.Rationale: capa not required at this time.

Event Description

It was reported that syringe 1ml ll bns was damaged on 14 occasions, plunger was loose on 11 occasions, was deformed on 8 occasions, and had foreign matter on 69 occasions.The following information was provided by the initial reporter: 14 syringes heavily deformed, 11 syringes without plunger/ loose plungers, 8 syringes with deformed end top, 69 syringes with brown spots.

• Brand Name: SYRINGE 1ML LL BNS
• 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: 12162875
• MDR Text Key: 262003622
• Report Number: 1213809-2021-00490
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309648
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• 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