MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ SF SALINE SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306553

Device Problems Particulates (1451); Packaging Problem (3007)

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

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 were 2 occurrences with seal integrity with a bd posiflush¿ sf saline syringe.The following information was provided by the initial reporter: it was reported that a particulate was caught in the seal of the packaging.

Manufacturer Narrative

H.6.Investigation: upon review of the returned samples, the identified defect has been confirmed.The non-conformance's were reviewed for this batch, and there was no record of any non-conformance associated with this defect for this batch.This is not a trending issue, there has not been a complaint for this type of issue previously.It is possible that this may have been caused by the breakdown of the red label application belt on the production line.

Event Description

It was reported that there were 2 occurrences with seal integrity with a bd posiflush¿ sf saline syringe.The following information was provided by the initial reporter: it was reported that a particulate was caught in the seal of the packaging.

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8575715
• MDR Text Key: 146501363
• Report Number: 9616657-2019-00204
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• PMA/PMN Number: K153481
• 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: 06/13/2019

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: 10/31/2021
• Device Catalogue Number: 306553
• Device Lot Number: 8311510
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other