MAUDE Adverse Event Report: O&M HALYARD, INC. CUSTOM LOWER EXTR DRAPE 130; SURGICAL DRAPES AND PACKS

Model Number	13232
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this complaint is not available for evaluation.A follow-up report will be provided upon the conclusion of the investigation.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
Fibers were coming off of drape.The clinician was performing a orthopedic procedure using guidewires at time of discovery.The clinician was concerned about patient risk of having fibers inserted in vessels.No patient injury or additional treatment was delivered.
Additional Manufacturer Narrative
The device history record was reviewed for the complaint lot number.The lot met all manufacturing process and quality specifications prior to release.No rework or special conditions were reported.Review of complaint photo one focused on a portion of the absorbent material along a back table cover with the film side up.A gloved finger points to the upper section of the absorbent material to denote some raised fibers.Photo two shows a zoomed section from the previous image, this image showed an angle that the raised fibers are clearer.Right below the gloved finger, the area looks abraded.A root cause was not identified.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: CUSTOM LOWER EXTR DRAPE 130
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA, S. DE. R. L. DE C. V.; av. hidalgo no. 6 esq; blvd. luis donaldo colosio; col.educativa, nogales sonora 84093 ; MX 84093
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19557125
• Report Number: 3005997949-2024-00007
• Device Sequence Number: 17327103
• Product Code: PUI
• UDI-Device Identifier: 30680651132322
• UDI-Public: 30680651132322
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: 13232
• Device Catalogue Number: 991013232
• Device Lot Number: AC23142201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown