MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERI-STRIPS; MESH, SURGICAL

Catalog Number	PSDA60ECH
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	06/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a peri-strip secure grip was "gelled over" and the plastic strip (liner) was not removed from the secure grip; the peri-strip was applied onto the stapler.It was further reported that the surgeon stapled with the plastic strip still on the peri-strip.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3 and h6.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: b1, b2, h1, h6 and h10.The device was not received for evaluation; therefore, a device analysis could not be completed.Peri-strips secure grip requires the paper backer to be removed prior to use.The instructions for use (ifu) state in step 8: ¿grasp protective liner pull tab from distal end of loading unit and carefully peel protective liner to expose adhesive and step 10: ¿inspect the adhesive surface on both sides of the loading unit to ensure all protective liner has been removed¿.The inner pouch contains a label to remind the user to remove the protective liner.The cause of the reported event was determined to be due to a use error.The ifu clearly indicates that the protective liner should be removed.The ifu also indicated the presence of adhesive and does not mention the necessity to apply glue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PERI-STRIPS
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10302664
• Report Number: 1416980-2020-04144
• Device Sequence Number: 11458216
• Product Code: FTM
• UDI-Device Identifier: 00085412658803
• UDI-Public: (01)00085412658803
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2021
• Device Catalogue Number: PSDA60ECH
• Device Lot Number: SP20E22-1452912
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 08/10/2020; 08/10/2021
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/24/2020; 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other