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

Catalog Number 306595

Device Problem Sticking (1597)

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

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 with the use of the bd posiflush¿ normal saline syringe there was an issue with difficult plunger movement.It was stated ¿the nurse found it difficult to push during use.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: ten samples were received for evaluation by one of our quality engineers.They were with the sealed packaging flow wrap.They had the plunger rod-rubber stopper, the tip cap and saline solution.The barrel labels confirm the lot# 7026895.The ten samples were tested for sustaining force.Eight (8) of them passed, having 9.60n the lowest reading and 15.60n the highest reading.The two that failed, one had 21.40n and the other 23,50n.The spec is<20n therefore failure mode is verified.Root cause could not be determined.A device history review was completed and there was no issues with plunger movement difficult during production run for batch 7026895.There were no quality notifications issued during the production of this batch listed in the complaint.Investigation conclusion: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.There were no issues documented about plunger movement difficult.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7574512
• MDR Text Key: 110582879
• Report Number: 1911916-2018-00309
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7026895
• Date Manufacturer Received: 12/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other