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

Model Number 309649

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/12/2019

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 a white foreign particle was found on the bd syringe luer-lok¿ tip's plunger stopper during use when drawing up liquid.The following information was provided by the initial reporter, translated from (b)(6) to english: "when the liquid lifts up, it is discovered that a white particle is present on the rubber.It is not clear what it is, so far it has not come loose.".

Event Description

It was reported that a white foreign particle was found on the bd syringe luer-lok¿ tip's plunger stopper during use when drawing up liquid.The following information was provided by the initial reporter, translated from dutch to english: when the liquid lifts up, it is discovered that a white particle is present on the rubber.It is not clear what it is, so far it has not come loose.

Manufacturer Narrative

H.6 investigation summary: one photo of a loose 5ml syringe containing approximately 6ml of fluid was received and evaluated.It was observed there was a small white foreign matter particle attached to the stopper in the fluid path.The particle was larger than level 2 in size and was rejectable per product specification.A physical sample is required for a more thorough evaluation and potential root cause determination.The composition of the foreign matter could not be identified based on the photo received; therefore, the root cause is undetermined.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.

• 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: 9528097
• MDR Text Key: 193916539
• Report Number: 1213809-2019-01315
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: 30382903096498
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309649
• Device Catalogue Number: 309649
• Device Lot Number: 9163898
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other