MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SALINE 10ML SYRINGE FILLED

Catalog Number 306565

Device Problem Material Twisted/Bent (2981)

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

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: photos were received for evaluation.The photos provided show syringe damage reported on the complaint therefore failure mode is verified.Syringe damage was induced by equipment.Possibly a jam occurred.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: this is the first complaint for the lot# 8044816 for the same defect or symptom.There was no documentation of issues for the complaint of batch 8044816 during this production run.Root cause description: syringe damage was induced by equipment.Possibly a jam occurred.

Event Description

It was reported that bd posiflush¿ saline 10ml syringe filled have deviated luer locks.The lur lock connection is bent and irregular with potential to leak.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported that bd posiflush¿ saline 10ml syringe filled have deviated luer locks.The lur lock connection is bent and irregular with potential to leak.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD POSIFLUSH¿ SALINE 10ML SYRINGE FILLED
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7758024
• MDR Text Key: 116705416
• Report Number: 1911916-2018-00444
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K982558
• 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: 09/06/2018

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 306565
• Device Lot Number: 8044816
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 09/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other