MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; FLUSH SYRINGE

Catalog Number 306595

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/29/2019

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 10 ml bd posiflush¿ normal saline syringe tip of barrel bent during use.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation: one sample was received.It has no packaging flow wrap and no saline solution.It has the plunger rod-rubber stopper, the tip cap and the barrel label confirms the lot# 8019588.The plunger rod- rubber stopper is at 4ml mark.The luer tip of the barrel is deformed.Failure mode is verified, however, being about 15 degrees inclined, it doesn¿t affect function of the syringe.Root cause is undetermined.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 10 ml bd posiflush¿ normal saline syringe tip of barrel bent during use.No serious injury or medical intervention was reported.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8336133
• MDR Text Key: 136769359
• Report Number: 1911916-2019-00165
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K982558
• 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: 03/05/2019

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: 01/31/2021
• Device Catalogue Number: 306595
• Device Lot Number: 8019588
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other