MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORTION SEPRAFILM; BARRIER, ABSORBABLE, ADHESION

Catalog Number 430105

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A healthcare professional reported that a seprafilm product was contaminated.When the foil pouch of the seprafilm was opened during an unspecified procedure, the clear pouch appeared to be contaminated with what was reported as blood; however, the spots were not able to be further clarified at this time.The device was removed prior to patient use; therefore, there was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: h6.The actual device was not available; however, a photograph of the sample was provided for evaluation.The spots that appeared to be blood are visible in the photographs.The pouch was opened in the field for use in an operating room setting; therefore, the pouch likely became contaminated outside the manufacturing plant.There are current controls in place to prevent this issue from occurring.The reported condition was verified.However, the cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SEPRAFILM
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORTION; deerfield IL
• MDR Report Key: 10049412
• MDR Text Key: 190756304
• Report Number: 1416980-2020-02675
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 430105
• Device Lot Number: 9BYSEP009
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1