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

Catalog Number 306547

Device Problem Difficult to Flush (1251)

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

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd posiflush¿ normal saline syringe plunger was difficult to move.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 306547, batch no.: 8332575.It was reported there is resistance to flushing that is causing the nurses to use more pressure than usual to flush lines.Verbatim: ¿we have had numerous accounts of issues with lot # 8332575 of the prefilled ns syringes.The most concerning is the resistance to flushing that is causing nurses to use more pressure than usual to flush lines.¿.

Event Description

It was reported that bd posiflush¿ normal saline syringe plunger was difficult to move.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no.: 306547, batch no.: 8332575.It was reported there is resistance to flushing that is causing the nurses to use more pressure than usual to flush lines.Verbatim: ¿we have had numerous accounts of issues with lot # 8332575 of the prefilled ns syringes.The most concerning is the resistance to flushing that is causing nurses to use more pressure than usual to flush lines.¿.

Manufacturer Narrative

H.6.Investigation summary: no samples displaying the condition reported are available for examination so we were unable to fully investigate this incident.There was no documentation of issues for the complaint of batch 8332575 during the production run.No root cause can be determined as no samples were received.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8488505
• MDR Text Key: 143972781
• Report Number: 1911916-2019-00357
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 306547
• Device Lot Number: 8332575
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other