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

Catalog Number 306572

Device Problem Short Fill (1575)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2020

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 there was an incorrect fill with a bd posiflush xs pre-filled flush syringe nacl 0.9%.This was discovered prior to use.The following information was provided by the initial reporter, translated from (b)(6) to english: when checking the closed packaging, it was found that there is 2,5 ml fluid only in the syringe.

Manufacturer Narrative

The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-05-05.H.6.Investigation summary: a device history record review was performed for provided lot number 9263969 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both picture and physical samples were provided for evaluation by our quality engineer team.Through examination of the samples, the syringe was observed incorrectly filled.It has been determined that this incident most likely resulted due to an error in the adjustment of the fill volume sensor machinery.We believe that this was an isolated incident with an unlikely recurrence.Our quality team will continue to monitor the production process for signs of this potential defect and any emerging trends.

Event Description

It was reported that there was an incorrect fill with a bd posiflush¿ xs pre-filled flush syringe nacl 0.9%.This was discovered prior to use.The following information was provided by the initial reporter, translated from dutch to english: when checking the closed packaging, it was found that there is 2,5 ml fluid only in the syringe.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 9970243
• MDR Text Key: 202568493
• Report Number: 9616657-2020-00059
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9263969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other