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

Model Number 306547

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306547 and lot number 1169511.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.It could be possible the customer is not using the product as intended.This product is designed for pushing the plunger rod down while expelling the saline solution.It is not designed for pulling the plunger rod back.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

Event Description

It was reported when using the bd posiflush¿ iv flush normal saline filled syringe the stopper separated from the plunger.The following information was provided by the initial reporter.The customer stated: "when pushing forward the flush works fine but when pulling back (for example, checking for blood return) the plastic plunger rod comes disconnected from the rubber stopper.".

• Brand Name: BD POSIFLUSH¿ IV FLUSH NORMAL SALINE 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: 12724294
• MDR Text Key: 283831472
• Report Number: 1911916-2021-01121
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: 1169511
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• 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