MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 10 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; PREFILLED SALINE SYRINGE

Catalog Number 306575

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 09/08/2020

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 an unspecified number of 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% experienced misaligned/jammed/insecure stoppers which was noted during use.The following information was provided by the initial reporter: today we received a complaint about b-d posiflush wwsp sp 10 ml.The syringes jam halfway through the flushing.One syringe still contained 5 ml and the other 7 ml.

Event Description

It was reported that an unspecified number of 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% experienced misaligned/jammed/insecure stoppers which was noted during use.The following information was provided by the initial reporter: today we received a complaint about b-d posiflush wwsp sp 10ml.The syringes jam halfway through the flushing.One syringe still contained 5ml and the other 7ml.

Manufacturer Narrative

H6: investigation summary: a device history record review was performed for provided lot number 0141847 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.As samples were unavailable for return, twenty retained samples of the same lot number were obtained from the manufacturing facility for further evaluation by our quality engineer.The twenty retained samples were inspected for plunger movement difficulties and no defects were identified.

• Brand Name: 10 ML BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: PREFILLED SALINE SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 10610925
• MDR Text Key: 211129107
• Report Number: 3002682307-2020-00292
• 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: 12/15/2020

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 Catalogue Number: 306575
• Device Lot Number: 0141847
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other