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 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had a hole in the packaging found before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "unfortunately, the hole in the picture is not really easy to see and is an example of several, i assume.After all, bd expects up to 10% defective packaging".

Manufacturer Narrative

Correction: the reporter of this complaint confirmed that this was not for a specific incident, but rather a follow up for more information regarding a field safety notice.The picture attached was from a bd communication sent, not from an issue the customer had.Thus, the complaint will be canceled.

Event Description

It was reported that the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% had a hole in the packaging found before use.The following information was provided by the initial reporter, translated from german to english: "¿unfortunately, the hole in the picture is not really easy to see and is an example of several, i assume.After all, bd expects up to 10% defective packaging.".

• 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: 10130013
• MDR Text Key: 203186913
• Report Number: 9616657-2020-00087
• 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: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other