MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE; SALINE FLUSH

Catalog Number 306574

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.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 there was no label found on a 5ml bd posiflush¿ syringe prior to use.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: a sample was received for evaluation by one of our quality engineers.It has no packaging flow wrap.It has the plunger rod-rubber stopper, the tip cap and saline solution.It has no barrel label therefore failure mode is verified.Possible root cause is a plunger rod labeler process variation.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.A device history review could not be completed as no batch# was provided.Capa not required for this event.

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7524285
• MDR Text Key: 108762185
• Report Number: 1911916-2018-00206
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K011982
• 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: 05/22/2018

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 Catalogue Number: 306574
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 04/25/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other