MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; VASCULAR ACCESS FLUSH

Model Number 306546

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

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.(b)(4).

Event Description

It was reported that 10 ml bd posiflush¿ normal saline syringe plunger rod got stuck on 7 occasions during use.The following information was provided by the initial reporter: material no.306546 batch no.0126434 it was reported that as the line is being flushed, the plunger rod will get stuck leaving approximately 2ml's remaining in the syringe.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number (b)(4) and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.As neither a physical sample nor a picture sample was available for return, our quality team was unable to complete a thorough sample investigation.Based on the investigation results, a cause related to the manufacturing process could not be determined for this incident.Our quality team will closely monitor the production process for signs of this potential defect and any emerging trends.

Event Description

It was reported that 10 ml bd posiflush¿ normal saline syringe plunger rod got stuck on 7 occasions during use.The following information was provided by the initial reporter: material no.(b)(4) batch no.0126434 it was reported that as the line is being flushed, the plunger rod will get stuck leaving approximately 2ml's remaining in the syringe.

• Brand Name: 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10551547
• MDR Text Key: 208758636
• Report Number: 9616657-2020-00153
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 0126434
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other