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

Catalog Number 301029

Device Problem Fungus in Device Environment (2316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd syringe luer-lok¿ tip had mold on it.No serious injury or medical intervention was reported.

Event Description

It was reported that bd syringe luer-lok¿ tip had mold on it.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation: 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.One photo of a loose syringe of unknown volume was received and evaluated.It was observed that there were three loose foreign matter particles with a brownish green color, on the flange of the barrel, outside the fluid path.The fm appears to be grease and at least one particle is lager than level 3 in size, which is rejectable per product specification.Potential root cause for the foreign matter defect is associated with the assembly or packaging process.

• Brand Name: BD SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8331354
• MDR Text Key: 136120568
• Report Number: 1213809-2019-00170
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 301029
• Device Lot Number: 8262720
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 01/28/2019
• Supplement Dates FDA Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other