MAUDE Adverse Event Report: O&M HALYARD, INC. BASICS FEMORAL ANGIOGRAPHY DRAPE; HYHL100 ANGIOGRAPHY DRAPE-NON-STERL 40

Model Number	79582
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
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 and complaint handling establishment of the basic* femoral angiography drape.The complaint component basic* femoral angiography drape, part number: 79582 is contract manufactured by gri medical & electronic technology co., ltd (fda registration number: 3004911384.A supplier corrective action (scar) was submitted to the manufacturer on january 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
A report was received from the customer that alleges the drape window was separating where the window joins material.This incident compromised sterility during the procedure.The customer reported there were three lots of drape utilized including: gl22282fxx, gl21331fxx & gl23098fxx; however, the customer could not verify which lot was the one that exhibited this issue during procedure.The customer indicated there was no patient injury or medical treatment required, only an impact to the sterile field during procedure.
Additional Manufacturer Narrative
Correction: initially this complaint was filed under complaint lot gl22282fxx.Manufacturing site noted that there were three potential lots shipped to customer including: gl22282fxx, gl21331fxx & gl23098fxx.The customer did not have a sample available for evaluation.A device history record review of the three potential complaint lots was performed.Incoming and final inspections were documented and found to be conforming.No similar issues were detected.Quality control reviews appearance and dimension of products.Quality performs a tear strength test for the pe film and sms material, the results of testing for these three lot numbers were all within acceptance criteria.Site evaluated retained sample of lot gl22282fxx.There was no separation issues noted.When the adhesive spraying equipment is turned off and then restarted, the initial amount of adhesive sprayed is minimal.According to work instructions, the operator should use a yellow label to identify this location so that it is removed during cutting process.Site investigators speculate that application of label and removal of this area may not have occurred in this instance.The defective quantity communicated by customer was 1 each.This appears to be an isolated incident.Complaint data was reviewed from january 2023 to january 2025, this is the first complaint related to a pe film detached issue for surgical drapes produced on same production line.Teammates were retrained on work instruction.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp-(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: BASICS FEMORAL ANGIOGRAPHY DRAPE
• Common Device Name: HYHL100 ANGIOGRAPHY DRAPE-NON-STERL 40
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD.; 1805 honggao road; xiuzhou industrial zone; jiaxing, zhejiang, cn 31403 1; CH 314031
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 21120752
• Report Number: 3014421917-2025-00001
• Device Sequence Number: 7436505
• Product Code: PUI
• UDI-Device Identifier: 30680651795824
• UDI-Public: 30680651795824
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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: 79582
• Device Catalogue Number: 79582
• 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: 01/06/2025
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/05/2025
• 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