MAUDE Adverse Event Report: O&M HALYARD, INC. ACMF SPECIALTY DRAPE-NON-STERL 18; SURGICAL DRAPES AND PACKS

Model Number	76885
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of 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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
There were large holes that presented in the seam of the drape during surgery.This caused a breech in sterility during operation.Additional information was requested on november 26, 2024, november 28, 2024, and december 2, 2024, and has not been received.
Additional Manufacturer Narrative
Correction to reported lot number in section d.The customer reported two potential lot numbers (ac24086261 & ac24140124).Site attempted on three occasions to clarify which lot number was involved in the incident, but the customer wasn't able to identify which of these two lots were.Investigation was therefore performed on both potential lot numbers.The device history record was reviewed for both potential complaint lots (ac24086261 & ac24140124).These lots met all manufacturing process and quality specifications prior to release.Sample pictures were provided, and incident was confirmed.Potential root cause was identified as incorrect gluing completed by operator.The following actions were taken as corrective actions: more clearly identified the non-stirred glue tank to prevent incorrect adhesive glue from being utilized.Evaluated use of stirred and non-stirred glue for assembly site, determined there was no change to product functionality associated with non-stirred glue use.Acquired new weights to cover the legging portion of drape during bonding and updated work instructions to include the usage of the new weights.Provided a personnel refresher on rubbing the bonded areas and the use of weights to ensure a proper bonding.Personnel of the involved manufacturing line were notified of the incident to raise awareness.

• Brand Name: ACMF SPECIALTY DRAPE-NON-STERL 18
• 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): LA ADA DE ACUNA, S. DE. R. L. DE C. V.; av. hidalgo no. 6 esq.; blvd. luis donaldo colosio; col.educativa, nogales, sonora, mexico 84093 ; MX 84093
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20987578
• Report Number: 3005997949-2024-00010
• Device Sequence Number: 15410064
• Product Code: PUI
• UDI-Device Identifier: 30680651768859
• UDI-Public: 30680651768859
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/16/2025

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: 76885
• Device Catalogue Number: 76885
• Device Lot Number: UNKNOWN
• 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: 11/21/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 01/16/2025
• 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