MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ NS FILLED SYRINGE

Catalog Number 306546

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/14/2018

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.

Event Description

It was reported with the use of the bd posiflush¿ ns filled syringe there was an issue with piece of plastic attached to insertion tip.

Manufacturer Narrative

The following field was updated due to corrected information: describe event or problem: it was reported with the use of the bd posiflush¿ ns filled syringe there were 2 issues with piece of plastic attached to insertion tip.Investigation: through evaluation of the returned sample units, our quality engineer team observed excess material/plastic attached to the tip of the barrels.A device history record review was performed for provided lot number 8232966 and the review did not reveal any detected quality issues during the production process that may have contributed to this incident.It has been determined that this incident most likely resulted from a molding process error that went undetected due to inadequate inspection and detection methodologies within the molding machine.In response to this issue, the current inspection and detection activities are under review to determine adequacy.A corrective and preventive action plan has been initiated to further investigate this issue and prevent its recurrence.

Event Description

It was reported with the use of the bd posiflush¿ ns filled syringe there were 2 issues with piece of plastic attached to insertion tip.

• Brand Name: BD POSIFLUSH¿ NS FILLED SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8206647
• MDR Text Key: 131775067
• Report Number: 9616657-2018-00081
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

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: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8232966
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other