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 07/24/2020

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 an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced damaged or open unit seals/packages where sterility was compromised.Product defect was noted prior to use.The following information was provided by the initial reporter: broken packaging, the lot number is on the "recall-list" that has been send out to all the customer 1th of july.

Manufacturer Narrative

H.6.Investigation: dhr was performed.The non-conformances were reviewed for this batch and there was no record of non-conformance associated with this batch.Although samples were not available for this reported incident, the damaged packaging is a known issue for the reported lot number (lot: 9248167).The package damage has been isolated to product manufactured on a single packaging line, which has ceased production since october 2019.All affected product has been placed on hold and a field safety notice, mds-20-1971, has been issued in response to this issue.A corrective and preventive action, capa#1472544 plan has been initiated to further investigate this defect and identify its exact cause.

Event Description

It was reported that an unspecified number of bd posiflush¿ xs pre-filled flush syringes nacl 0.9% experienced damaged or open unit seals/packages where sterility was compromised.Product defect was noted prior to use.The following information was provided by the initial reporter: broken packaging, the lot number is on the "recall-list" that has been send out to all the customer 1th of july.

• 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: 10452161
• MDR Text Key: 205480433
• Report Number: 9616657-2020-00132
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 306572
• Device Lot Number: 9248167
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MDS-20-1971
• Patient Sequence Number: 1
• Patient Outcome(s): Other