MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL BNS; PISTON SYRINGE

Catalog Number 301029

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Seven photos each displaying the same loose 10ml syringe were received and evaluated.It was observed the syringe had multiple deformations near the 4ml and 5ml markings.There was also plunger rod damage consistent with the barrel damage and significant damage on the thumb rest.The damage was rejectable per product specification.Potential root cause for the damaged barrel defect is associated with the assembly process.It was likely due to a part caught in the assembly dial.A barrel caught in the dial was found during the manufacture of this batch and a requalification was performed.It is possible a limited number pieces were able to escape detection.No corrective actions are necessary based on the defective rate identified.Batch 8229974 is considered in compliance with our product specification requirements.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.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.

Event Description

It was reported that syringe 10ml ll bns was damaged, but still operable and that the plunger rod is damaged.The following information was provided by the initial reporter: "visual and microscopic inspections revealed that the barrel is dented and cracked; the plunger is cracked and deformed and the thumb rest on the plunger is deformed".

• Brand Name: SYRINGE 10ML 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10624683
• MDR Text Key: 221835406
• Report Number: 1213809-2020-00690
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K980987
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 301029
• Device Lot Number: 8229974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• 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
• Patient Outcome(s): Other