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

Catalog Number 430105

Device Problem Defective Device (2588)

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 found a transparent piece of film; inside the foil pouch of a seprafilm product.The event occurred during an unspecified procedure when the foil pouch of the seprafilm was opened.The device was removed prior to patient use; therefore, there was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: d10, h3 and h6.The device was received for evaluation.During visual examination, a small flat square piece of pliable plastic, approximately one half inch by one half inch was attached to the outer carton.The reported condition was verified.While the exact cause could not be determined; the most probable cause was a small punch out piece of polyolefin from the thumb notch of the clear pouch was not completely cleared and inadvertently ended up in the foil pouch.There are current controls in place to prevent this issue from occurring.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 CORPORATION; deerfield IL
• MDR Report Key: 10052518
• MDR Text Key: 190904792
• Report Number: 1416980-2020-02686
• 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
• 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: No Information
• Device Catalogue Number: 430105
• Device Lot Number: 9BYSEP009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/13/2020
• 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