MAUDE Adverse Event Report: O&M HALYARD, INC. PADDED HEAVY DUTY BACK TABLE COVER, 60IN X 90IN / 152 CM X 228 CM; SURGICAL ACCESSORIES

Model Number	29269
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
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.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 bug was found on the back table cover in a sterile pack, and was removed from the operating room.There was a delay in surgery for 15 minutes.
Additional Manufacturer Narrative
Received a section of a full-sized sample.The section received measures approximately 7cm x 7.5cm.The sample was evaluated under ambient light conditions.The 7cm x 7.5cm section of sample consists of one layer of heavier darker film, and a laminated light blue film with a nonwoven layer.The nonwoven side of the sample exhibits a foreign material which appears embedded into the nonwoven fibers of the sample.The foreign material measures approximately 1cm long and at the widest point measures 8mm.The sample was turned over for inspection.The foreign material is not observed on the film side.The foreign material was viewed under magnification.The foreign material has the appearance of the body of a winged insect which is entangled or entwined with the nonwoven fibers and therefore embedded in the nonwoven layer.The light blue film was peeled away and separated from the nonwoven layer.The apparent winged insect remained on the nonwoven layer, confirming it is embedded into the fibers of the nonwoven layer.Based on incident description and sample evaluation results, no root cause was established, both lexington and nogales have controls in place to monitor the insect presence at their respective facilities.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: PADDED HEAVY DUTY BACK TABLE COVER, 60IN X 90IN / 152 CM X 228 CM
• Common Device Name: SURGICAL ACCESSORIES
• 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: 17252934
• Report Number: 3005997949-2023-00005
• Device Sequence Number: 6840381
• Product Code: PUI
• UDI-Device Identifier: 30680651292699
• UDI-Public: 30680651292699
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 29269
• Device Catalogue Number: 29269
• Device Lot Number: AC23008103
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown