MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 1ML LS 200 S/C; PISTON SYRINGE

Catalog Number 309659

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one loose 1ml syringe with needle attached in an opened blister pack from batch 9127931 (p/n 309659) was received and evaluated.There was approximately 0.15ml of clear fluid inside.It was observed there was a small hole in the top web of the packaging with what appeared to be a burn mark on the edge of the hole on the inside.There was also a small brown, undamaged insect in the fluid path suspended in the fluid.Potential root cause for the foreign matter defect could not be determined.There was a small hole in the blister pack and was unclear when the insect was introduced.Additionally, this product was released from the manufacturing site for use in may 2019 and stored and/or distributed under unknown conditions since then.Since root cause could not be defined, no corrective actions are necessary at this time.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.Investigation conclusion: since root cause could not be defined, no corrective actions are necessary at this time.

Event Description

It was reported that the syringe 1ml ls 200 s/c experienced foreign matter in the device cannula/needle/syringe or other fluid path component, and a damaged or open unit package/seal where sterility was compromised.The following information was provided by the initial reporter: material no.309659 batch no.9127931 this syringe has a pinhole in the packaging, as a bug entered the sterile packaging and climbed into the slip tip of the syringe and died in the barrel of the syringe.When staff went to fill the syringe with solution, they noticed the bug.

• Brand Name: SYRINGE 1ML LS 200 S/C
• 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: 11599551
• MDR Text Key: 262723937
• Report Number: 1213809-2021-00196
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309659
• Device Lot Number: 9127931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2019
• 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