MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

Catalog Number 309657

Device Problem Air Leak (1008)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).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 there is a problem with the plynger or the hub of a 3 ml bd luer-lok¿ disposable syringe with bd luer-lok¿ tip, as it is drawing back air when used during venipuncture.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Since the lot number is unknown, we were unable to examine the device history record.No root cause can be determined as no samples were received.No capa is required.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: 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7475645
• MDR Text Key: 107220338
• Report Number: 1213809-2018-00245
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other