MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problem Packaging Problem (3007)

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

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.However, it could have happened that a jam occurred at the packaging flow wrapper inducing the open seals.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Root cause description: posiflush packaging process.It could have happened that a jam occurred at the packaging flow wrapper inducing the open seals.Rationale: capa not required at this time.

Event Description

It was reported that the bags were not sealed in shipper and sterility is compromised with a 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: it was reported that all the bags inside the box were not sealed.

Manufacturer Narrative

The following fields have been updated with corrected information: h.3 reason code for no evaluation: other.H.3.If other specify: see h.10 h3 other text : see h.10.

Event Description

It was reported that the bags were not sealed in shipper and sterility is compromised with a 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: it was reported that all the bags inside the box were not sealed.

• Brand Name: 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9946688
• MDR Text Key: 187794732
• Report Number: 1911916-2020-00371
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 306575
• Device Lot Number: 9260321
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other