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

Catalog Number 306546

Device Problem Structural Problem (2506)

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

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8232966; medical device expiration date: 2021-07-31; device manufacture date: 2018-08-20; medical device lot #: 8192986; medical device expiration date: 2021-06-30; device manufacture date: 2018-07-11.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 were 2 issues of an extra piece of sharp plastic on the tip of the syringe.This happened once with lot# 8232966 and once with lot# 8192986.

Manufacturer Narrative

Investigation: lot numbers 8192986 and 8232966 were provided for evaluation by our quality engineer team.A device history record review was performed for each provided lot number and the reviews did not reveal any detected quality issues during the production process that could have contributed to the reported incident.Samples were received for lot number 8232966.Through inspection of the returned samples, our quality engineer team observed excess material/plastic attached to the tip of the barrels.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.Batch code: 8192986: based on the investigation, the root cause cannot be determined as a sample was not provided.Batch code: 8232966: the root cause may be related to moulding pin wear and inspection and detection methodology inadequacy on the moulding machine.

Event Description

It was reported with the use of the bd posiflush¿ ns filled syringe there were 2 issues of an extra piece of sharp plastic on the tip of the syringe.This happened once with lot# 8232966 and once with lot# 8192986.

• Brand Name: BD POSIFLUSH¿ NS FILLED SYRINGE
• Type of Device: FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8233236
• MDR Text Key: 133200935
• Report Number: 9616657-2018-00091
• 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: 02/15/2019

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 Catalogue Number: 306546
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 12/21/2018
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other