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

Catalog Number 306575

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 04/21/2020

Event Type  malfunction  

Manufacturer Narrative

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 the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% was aspirating during use while attached to the "cvc lumen with tego caps" when blood pulled through it and splashed/squirted onto the writer and patient's hands.The following information was provided by the initial reporter: "aspirated using this syringe while still attached to pt's cvc lumen with tego caps, blood pulled through syringe and splashed/squirted onto writer and patients hands.".

Event Description

It was reported that the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% was aspirating during use while attached to the "cvc lumen with tego caps" when blood pulled through it and splashed/squirted onto the writer and patient's hands.The following information was provided by the initial reporter: "aspirated using this syringe while still attached to pt's cvc lumen with tego caps, blood pulled through syringe and splashed/squirted onto writer and "patient's" hands.".

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9325904.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.As samples were unavailable for return, our quality team was unable to perform a thorough sample investigation.Posiflush sp syringes are intended to be used to clean only in-situ vascular access devices (vad) by flushing the saline solution through the catheter into the vein.Once done, the syringe must be disposed of since it is for single use only.According to the reported issue, the syringe was used to aspire, so blood was pulled through the syringe passing the stopper and splashing on patient and user.Therefore, it can be determined that the syringe was misused.At this time, corrective action has not been determined necessary.It is important to carefully follow the instructions for use when using the posiflush product.

• Brand Name: BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 10083196
• MDR Text Key: 194336288
• Report Number: 3002682307-2020-00165
• 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: 06/23/2020

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: 10/31/2022
• Device Catalogue Number: 306575
• Device Lot Number: 9325904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 05/04/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other