MAUDE Adverse Event Report: O&M HALYARD, INC. CUSTOM SPLITIMPERV SHEETS 60X70 115; SURGICAL DRAPES AND PACKS

Model Number	79330
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this complaint was not available 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, and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.
Event or Problem Description
The defective drape had adhesive that did not stick.Water seeped through the drapes onto the patient and over the surgical field.The patient was undergoing an arthroscopy procedure at time of occurrence.
Additional Manufacturer Narrative
No sample or photos were provided for evaluation.The nonconformance database was reviewed, no contributing nonconformances were found.The reporter did not provide a lot number, therefore the site is unable to perform a device history record review to determine if anything happened during the lot manufacture.Provided the limited information (no lot and no samples), it's difficult to further evaluate and identify a root cause.There is no trend for this issue and no other complaints where the tape has unattached.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 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 SPLITIMPERV SHEETS 60X70 115
• Common Device Name: SURGICAL DRAPES AND 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, mexico 84093 ; MX 84093
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19209969
• Report Number: 3005997949-2024-00004
• Device Sequence Number: 12771117
• Product Code: PUI
• UDI-Device Identifier: 30680651793301
• UDI-Public: 30680651793301
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: 79330
• Device Catalogue Number: 991079330
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/11/2024
• 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