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

Catalog Number 306546

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that blood leaked past the stopper of a 10 ml bd posiflush¿ normal saline syringe.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

No sample or photo was available for evaluation by bd.A device history record was performed on the reported lot and found zero defects recorded during production.Bd was unable to determine the root cause or corrective actions required to prevent reoccurrences as a sample was not available for evaluation.

• Brand Name: 10 ML 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: 7426084
• MDR Text Key: 105440611
• Report Number: 1911916-2018-00152
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• 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: 04/20/2018

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: 10/31/2020
• Device Catalogue Number: 306546
• Device Lot Number: 7292773
• Initial Date Manufacturer Received: 03/28/2018
• Initial Date FDA Received: 04/12/2018
• Supplement Dates Manufacturer Received: 03/28/2018
• Supplement Dates FDA Received: 04/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other