MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE FLUSH SYRINGE

Catalog Number 306575

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 2 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% experienced difficult plunger movement.The following information was provided by the initial reporter: material no: 306575, batch no: 0210093.Date of incident: (b)(6) 2020.Number of defective product(s): 2.Concern description: difficult to flush/ advance plunger.As a result nurse thinks iv catheter not in place correctly.(but in reality the flush is defective).

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided material number 306575 and lot number 0210093.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h.10.

Event Description

It was reported that 2 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% experienced difficult plunger movement.The following information was provided by the initial reporter: material no: 306575 batch no: 0210093.Date of incident: (b)(6) 2020.Number of defective product(s): 2 concern description: difficult to flush/ advance plunger.As a result nurse thinks iv catheter not in place correctly.(but in reality the flush is defective).

• Brand Name: 10 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11168273
• MDR Text Key: 230283046
• Report Number: 1911916-2020-01173
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 306575
• Device Lot Number: 0210093
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1