MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Short Fill (1575)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A 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¿ xs pre-filled flush syringe nacl 0.9% was found only "half full" before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "when opening the packaging, the hcw notices that the syringe is half full.".

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was found only "half full" before use.The following information was provided by the initial reporter, translated from french to english: "when opening the packaging, the hcw notices that the syringe is half full.".

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9248167 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To further investigate this issue, one picture sample and one physical sample were returned for evaluation by our quality engineer team.Through examination of the returned samples, the syringe was observed incorrectly filled.It has been determined that this incident most likely resulted from an intermittent issue caused by the gripper component in the machine that aligns the tip cap onto the syringe.The gripper component was removed and realigned correctly, which appeared to resolve this issue.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 9808199
• MDR Text Key: 204574216
• Report Number: 9616657-2020-00040
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9248167
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other