MAUDE Adverse Event Report: O&M HALYARD, INC. SURGICAL DRAPES AND PACKS; SURGICAL PACKS

Model Number	77744
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The tegaderm tore during use, compromising ophthalmic sterile field.
Additional Manufacturer Narrative
The product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.La ada de acuna, is the manufacturer of the halyard branded kit.The complaint component tegaderm, part number 70019185 is manufactured by mylan technologies, inc.(fda registration 1220747).A supplier corrective action (scar) was submitted to the manufacturer on 28jul2023.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.Device not returned.
Additional Manufacturer Narrative
The product involved in the event was not available for return.The device history record was reviewed for the lot number of the unit.The lot met all manufacturing process and quality specifications prior to release.No abnormalities were reported during the manufacturing of this product.No root cause can be established due to the lack of sample or pictures.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.

• Brand Name: SURGICAL DRAPES AND PACKS
• Common Device Name: SURGICAL PACKS
• Manufacturer (Section D): O&M HALYARD, INC.; 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: 17419082
• Report Number: 3005997949-2023-00006
• Device Sequence Number: 20619089
• Product Code: KKX
• UDI-Device Identifier: 30680651777448
• UDI-Public: 30680651777448
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862801
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: 77744
• Device Catalogue Number: 107774480
• Device Lot Number: AC2302005D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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