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

Catalog Number 306572

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2020

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.(b)(4).

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% packaging was found damaged before use.The following information was provided by the initial reporter: "the customer experienced error with the posiflush xs 10 ml in april, when a field notice was sent out regarding a damage on the packaging.The same customer experienced the same error now with posiflush xs 10 ml ( but with a different lot-nr 0076414) which is not on the field notice).She describes an error/damage with the packaging.The customer had 5 boxes (with same lot) with 30 syringes each box, and discovered errors with all products.".

Manufacturer Narrative

H.6.Investigation summary a device history record review was performed for provided lot number 0076414 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.As samples were unavailable for return, our quality team could not complete a thorough sample investigation.Recently, a field safety notice was communicated related to this potential defect; however, the lot number reported for this incident is not a part of the notice and was manufactured on a separate production line.Our quality team will continue to closely monitor the production process for signs of this potential defect.See h.10.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% packaging was found damaged before use.The following information was provided by the initial reporter: "the customer experienced error with the posiflush xs 10 ml in april, when a field notice was sent out regarding a damage on the packaging.The same customer experienced the same error now with posiflush xs 10 ml ( but with a different lot-nr 0076414) which is not on the field notice).She describes an error/damage with the packaging.The customer had 5 boxes (with same lot) with 30 syringes each box, and discovered errors with all products.".

• Brand Name: BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 10347676
• MDR Text Key: 202962091
• Report Number: 9616657-2020-00115
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 306572
• Device Lot Number: 0076414
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other