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

Catalog Number PSDA60ECH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported two (2) peri-strips were placed on a patient "with the adhesive covering still on".The event occurred in the operating room and was further described as ¿the technician placed glue on top of the adhesive liner instead of removing the liner.A different technician switched in midway through the procedure.The surgeon then placed the peri-strips onto the patient¿s abdomen in that condition.The technician then noticed that the per-strips looked different and realized the error; however, the procedure was completed with the per-strips left in with liners attached as the surgeon stated they did not have a lot of room to go back and remove the liners.At the time of the follow up the liners were in the patient¿.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: b5, d4, h6 and h10.B5: upon follow up the surgeon confirmed that the labeling instruction were not followed.D4: lot #: sp20i23-1478080 or sp21f17-1545842.H10: the device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Although the lot number was not provided, a search was performed to determine what product lots were shipped to the reporter's facility and lot numbers sp20i23-1478080 and sp21f17-1545842 were identified.A batch review was conducted for both lots and there were no deviations found related to this reported condition during the manufacture of these lots.The product consists of a loading unit which includes two (2) buttresses, one for the anvil and one for the cartridge side of the stapler.Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces.The instructions for use (ifu) for the product contains images and instructions for proper loading of the buttress onto the stapler (steps 8-10).The product labeling instructs the end user to carefully peel the protective liner to expose the adhesive and repeat this step for the opposite side of the loading unit and to inspect the adhesive surface on both sides of the loading unit to ensure all the protective liner has been removed.Also, included in the ifu, the liner is identified with an instruction to ¿pull tab to remove.¿ in addition to the ifu, there is an illustration/graphic label on the product inner pouch that shows to peel the protective liner as an additional reminder (¿pull tab to remove¿).The prescribed ifu instructions and labeling provided clearly instruct the user to remove the liner before use.There is also no alternative method provided within the product packaging for attaching the buttress to the stapler.The user must remove the liner to expose the adhesive in order for the product to adhere to the surfaces of the stapler.For this reported complaint the initial surgical technician used a glue found in the operating room that was not provided with the product to attach the buttresses to the stapler.The cause of the condition was determined to be a user error (surgical technician placed glue on top of the adhesive liner instead of removing the liner) as the surgical technician did not follow the peri-strips dry (staple line reinforcement with veritas collagen matrix with secure grip technology) ifu or the label/illustration on the product packaging.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: it was reported the patient underwent an unspecified laparoscopic procedure in which peri-strips were used.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information, b5: upon follow up it was reported that "there were no post-operative foreign body complications to date associated with leaving the peri-strip liner implanted within the patient".Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PERI-STRIPS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave w; saint paul MN 55114
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12416314
• MDR Text Key: 269612443
• Report Number: 1416980-2021-05403
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K192615
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PSDA60ECH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Other