MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PRE-FILLED SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

Event Type  malfunction  

Event Description

It was reported that bd posiflush¿ pre-filled syringe plunger would not move.The following information was provided by the initial reporter: it was reported that the rn reported that the plunger would no longer move.Verbatim: per report - the rn was pushing the fluid from the flush into the line after starting an iv and stopped pushing.The plunger would no longer move.This makes it seem as if the iv is bad.This could also be an issue if you are flushing medications like adenosine which has a very short half life.

Manufacturer Narrative

Investigation summary: it was reported that the plunger would no longer move.To aid in the investigation, one sample was received for evaluation by our quality team.A visual inspection was performed.The rubber stopper is at the 2.5ml mark of the scale and no defects or imperfections were observed.The sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the result was within specification.It could be possible that parts that are towards the high specification limit are related to the symptom reported by the customer since they require extra force than normal to expel the solution.A device history record review was completed for provided material number 306546, lot number 1203808.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Previous investigations have revealed that improper silicone application within the syringe barrel can create plunger resistance.Several quality initiatives have been implemented on our manufacturing line to ensure that the silicone application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the silicone is uniformly applied to the syringe barrel.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Capa not required at this time.

• Brand Name: BD POSIFLUSH¿ PRE-FILLED SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12715742
• MDR Text Key: 284866859
• Report Number: 1911916-2021-01116
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 10/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 1203808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1