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

Catalog Number 306575

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Infection (1930)

Event Date 01/04/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 infection occurred in the line used with the bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: "infections in line occuring where using posiflush sp.Confusion as to whether putting packet into sterile field and which part is sterile.Posiflush used in all incidences and unsure of infection origin.".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided lot number 0230149.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As samples were unavailable for return, forty retained samples of the same lot number were obtained from the manufacturing facility for evaluation by our quality engineer team.The samples were all analyzed for sterility and no signs of microbial growth were identified after fourteen days.Per the investigation results, there are no specific circumstances from the manufacturing process that could explain the reported incident.This is a very unusual circumstance.All processes which could affect the sterility of the product have been reviewed with no issues found.The sterility process was carried out with no issues and the sterility test performed on the retained displayed no issues.H3 other text : see h.10.

Event Description

It was reported that an infection occurred in the line used with the bd posiflush¿ sp pre-filled flush syringe nacl 0.9%.The following information was provided by the initial reporter: "infections in line occuring where using posiflush sp.Confusion as to whether putting packet into sterile field and which part is sterile.Posiflush used in all incidences and unsure of infection origin.".

• Brand Name: BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11233937
• MDR Text Key: 230782047
• Report Number: 1911916-2021-00058
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 306575
• Device Lot Number: 0230149
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other