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

Catalog Number 306575

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that fluid would not release from the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% due to resistant plunger movement.The following information was provided by the initial reporter: "when pushing the saline through an iv catheter it is giving a lot of resistance and sometimes fluid will not release at all.I was informed that this incident has occurred on several occasions.".

Manufacturer Narrative

H6: investigation summary.A device history record review was completed for provided material number 306547 and lot number 0281381.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one sample was received for evaluation by our quality team.The sample came in a plastic bag with no packaging flow wrap, or tip cap and the rubber stopper all the way down.A visual inspection was performed and no damages or imperfections were observed.The sample was then tested for sustaining force and, although on the higher end, the result was within specification.It could be possible that the customer noticed that more force than normal was required to expel the solution.Based on the investigation with the sample analysis the symptom reported by the customer could not be confirmed.

Event Description

It was reported that fluid would not release from the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% due to resistant plunger movement.The following information was provided by the initial reporter: "when pushing the saline through an iv catheter it is giving a lot of resistance and sometimes fluid will not release at all.I was informed that this incident has occurred on several occasions.".

• Brand Name: BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11320075
• MDR Text Key: 257374036
• Report Number: 1911916-2021-00115
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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: Health Professional
• Device Catalogue Number: 306575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1