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

Model Number 306547

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples were received.No photos were provided.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 record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.This is the 1st complaint for lot # 9274698 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: the syringe is designed to flush the iv lines by pushing down the plunger rod-rubber stopper; the plunger rod shouldn¿t be pulled up.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the 1st bd posiflush¿ normal saline syringe was hooked up to the catheter line during use, and when pulled back, only drew air.A 2nd syringe was hooked up to the line, and when pulled back, began leaking blood past the plunger.This complaint was created to capture the 3rd of 4 related incidents.The following information was provided by the initial reporter: "(b)(6) 2019 fistula- syringes with blood leak.Same cube.Same lot number 9260372.With first pull back on the syringe.One catheter, on fistula.(b)(6) 2019 catheter- another syringe with same lot number lot number would not infuse past 4ml.Going to rinse back and attached syringe to infuse.Locked at 4 ml.Able to pull back and try to reinfuse but still stopped at 4 ml.Unable to even infuse into the red bucket.(b)(6) 2020 syringe pulled air when pulling back from catheter line.Lot number 9274698, hooked up a second syringe and pulled back and blood leaked when pulling back.Same lot number.(b)(6) 2020 flushing a catheter, blood leaked everywhere from inside syringe.Lot 9274698." "where on the syringe did the leak occur? the plunger.".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9630057
• MDR Text Key: 195219668
• Report Number: 1911916-2020-00037
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2020

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: 09/30/2022
• Device Model Number: 306547
• Device Catalogue Number: 306547
• Device Lot Number: 9274698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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
• Patient Outcome(s): Other