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

Catalog Number 306572

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 a bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was not sealed.The device was not used and there was no report of injury or medical interventions.

Event Description

It was reported that a bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was not sealed.The device was not used and there was no report of injury or medical interventions.

Manufacturer Narrative

Investigation summary: no sample available.Complaint trending review for the lot for this issue reveals this is the first complaint for this lot.A dhr review was completed for this batch; and the non-conformances reviewed; there were no non-conformances associated with this defect.Unconfirmed.Investigation comments: this weak seal may be as a result of a worn gasket where excessive heat has been applied to the material causing an insufficient seal.Preventative maintenance has been revised and implemented since the manufacture of this batch, including extra attention and gasket replacement more frequently.Due to the absence of a sample, retained sample, or photo the complaint could not be substantiated.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 7538119
• MDR Text Key: 109234744
• Report Number: 9616657-2018-00024
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 306572
• Device Lot Number: 7013878
• Date Manufacturer Received: 11/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other