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

Catalog Number 306565

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/01/2018

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 during use of the bd posiflush¿ saline 10ml syringe there was too much resistance in the moment of injecting the saline solution.

Event Description

It was reported that during use of the bd posiflush¿ saline 10ml syringe there was too much resistance in the moment of injecting the saline solution.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.

• Brand Name: BD POSIFLUSH¿ SALINE 10ML SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8203825
• MDR Text Key: 131705049
• Report Number: 1911916-2018-00785
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065653
• UDI-Public: 382903065653
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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: 02/28/2021
• Device Catalogue Number: 306565
• Device Lot Number: 8044817
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other