MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SF SALINE SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306499

Device Problem Short Fill (1575)

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

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the stopper in the bd posiflush¿ sf saline syringe was "thicker" at the end, and the pre-filled solution was "about.4 ml's" under specification.All defects were found during use.The following information was provided by the initial reporter: "the issue is that we have a new version of the posiflush syringe where the rubber stopper at the end is thicker than the previous one, and i was wondering if the dimensions on the new posiflush syringe are different than the old model.Because the ones from the new lot are reading about.4 ml's under.".

Manufacturer Narrative

Investigation: two samples were received.One sample is a 306499 and the other one is a 306500.Both came in sealed packaging.Visual inspection was performed finding them both acceptable with no defects.They are different product designs; therefore, the stoppers are different.The 306500 is not anymore produced by our company.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.

Event Description

It was reported that the stopper in the bd posiflush¿ sf saline syringe was "thicker" at the end, and the pre-filled solution was "about.4 ml's" under specification.All defects were found during use.The following information was provided by the initial reporter: "the issue is that we have a new version of the posiflush syringe where the rubber stopper at the end is thicker than the previous one, and i was wondering if the dimensions on the new posiflush syringe are different than the old model.Because the ones from the new lot are reading about.4 ml's under.".

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9295924
• MDR Text Key: 194822777
• Report Number: 1911916-2019-01171
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• 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,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306499
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other