MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD HAND DRAPE 114 IN. X 142 IN. 289 CM X 360 CM; SURGICAL DRAPES AND PACKS

Model Number	13227
Medical Device Problem Codes	Product Quality Problem (1506); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not available for return.O&m halyard, inc.Is the specification developer of the halyard hand drape 114 in.X 142 in./ 289 cm x 360 cm - handi-bin.The complaint hand drape is contract manufactured by lianyungang aiyeh non-woven products co., ltd.(fda registration number (b)(4)).A supplier corrective action request (scar) was submitted to the manufacturer on march 7, 2025.A follow-up report will be provided upon conclusion of investigation and response by the manufacturer.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
The customer reported there is linting in the control plus area of the drape.Per the customer, the staff was having to clean instruments carefully to ensure "fluff" did not come into the surgical wound.There was 10-20 minute delay during procedure due to having to ensure debris removal.No lint went into the patient's wound.
Additional Manufacturer Narrative
No samples were available for evaluation.Device history records for two complaint lots were reviewed.No issues were documented in the production records, no similar defects were detected through inspection processes.No deviations were reported during manufacture.Process evaluation found that friction likely caused reinforcement piece to fluff.This is the second complaint for fabric linting from jan 2024 to mar 2025, the cpm (complaints per million) is (b)(4).There is no negative trend for this issue for the complaint product.Assembly operators have been notified.Operators will clean the non-woven fabric cut pieces to prevent the generation of debris.Operators have been retrained.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: HALYARD HAND DRAPE 114 IN. X 142 IN. 289 CM X 360 CM
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): LIANYUNGANG AIYEH NON-WOVEN PRODUCTS CO., LTD.; no.9 yunyang rd; lianyungang jiangsu, china
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 21721573
• Report Number: 3014421917-2025-00010
• Device Sequence Number: 21185803
• Product Code: PUI
• UDI-Device Identifier: 30680651132278
• UDI-Public: 30680651132278
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: 13227
• Device Catalogue Number: 101322703
• Device Lot Number: CA24082XXX, CA24064XXX
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/28/2025
• 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