MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER LOK SYRINGE; PISTON SYRINGE

Catalog Number 301035

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that before use of the bd¿ luer lok syringe there was a hair inside a syringe.The following information was provided by the initial reporter: material no.301035, batch no.8023808."it was reported that there was hair found inside the syringes.".

Event Description

It was reported that before use of the bd¿ luer lok syringe there was a hair inside a syringe.The following information was provided by the initial reporter: material no.301035 batch no.8023808."it was reported that there was hair found inside the syringes.

Manufacturer Narrative

Investigation: one (1) photo was received by our quality team.The photo appears to show a faint line in the syringe indicating a possible fiber in the syringe.However, without a physical sample to analyze the composition of the fiber can't be determined.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.Without a physical sample to analyze the foreign matter (fm) that appears to be in the syringe cannot be identified; therefore, potential root causes cannot be determined.

• Brand Name: BD LUER LOK SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8499578
• MDR Text Key: 141760505
• Report Number: 1911916-2019-00366
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 301035
• Device Lot Number: 8023808
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other