MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306424

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 that the bd posiflush¿ heparin lock flush syringe cracked during use and leaked medication.

Manufacturer Narrative

Investigation summary: bd was unable to perform a thorough investigation as no sample was provided.Dhr review shows there was no documentation of issues for the complaint of batch 811681n during this production run.Root cause description: root cause is undetermined.Rationale: 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.

Event Description

It was reported that the bd posiflush¿ heparin lock flush syringe cracked during use and leaked medication.

• Brand Name: BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8104218
• MDR Text Key: 128603855
• Report Number: 1911916-2018-00659
• Device Sequence Number: 1
• Product Code: NZW
• UDI-Device Identifier: 30382903064244
• UDI-Public: 30382903064244
• Combination Product (y/n): N
• PMA/PMN Number: K090680
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 306424
• Device Lot Number: 811681N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other