MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SYRINGE LUER-LOK TIP W/TIP SHIELD BULK NON-STERILE; PISTON SYRINGE

Catalog Number 301073

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd¿ syringe luer-lok tip w/tip shield bulk non-sterile was contaminated with unknown brown substance.

Manufacturer Narrative

Investigation summary: one photo and one 3ml ll syringe sample inside an opened blister package were received.The physical sample appeared to match the one depicted in the photo.The package used was from a different batch #8253851 and different product (p/n 305060) from one reported.A visual evaluation of the sample determined an embedded foreign matter defect.Multiple brown particles were observed embedded in the barrel wall above the 3ml mark as well as within the flange.At least one particle was larger than level 3 in size, which is rejectable per product specification.The barrel was confirmed to be from mold c-238 cavity 78.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.Potential root cause for the embedded foreign matter defect is associated with the molding process.No corrective actions are necessary based on the defective rate identified.

Event Description

It was reported that bd¿ syringe luer-lok tip w/tip shield bulk non-sterile was contaminated with unknown brown substance.

• Brand Name: BD¿ SYRINGE LUER-LOK TIP W/TIP SHIELD BULK NON-STERILE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8204013
• MDR Text Key: 131762526
• Report Number: 1213809-2018-00938
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 301073
• Device Lot Number: 8154723
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other