MAUDE Adverse Event Report: O&M HALYARD, INCL SURGICAL LOWER EXTR DRAPE 12; SURGICAL DRAPES AND PACKS

Model Number	42306
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was returned for evaluation.Sample evaluation is in progress.A device history record review was conducted.No nonconformances or issues were noted during manufacture that could contribute to the complaint incident.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 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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
Staff opened the drapes aseptically using the inner wrapper.When they checked the inner wrapper (csr wrap) for holes they found pin holes in the wrapper.This contaminated the whole back table and caused a delay in surgery.
Additional Manufacturer Narrative
One (1) product package with one (1) csr wrap inside was received.No back table cover sample was received, only the csr wrap.The sample was evaluated under ambient light conditions.The sample arrived loosely folded inside the product package.The sample was laid out on the lab table for inspection.The sample arrived with a circled area indicating the location of holes.The holes measures approximately 1mm or less.The holes were viewed under magnification.The holes are situated only inside the bond points.The bond points are damaged.The remaining sheet was inspected for visual damages.No others were observed.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.A root cause could not be determined for the issue reported.This is the second incident reported in the past five years, no upward trend for this issue noted.Manufacturing personnel were notified for awareness.The device history record was reviewed for the lot number of the manufactured unit.The lot met all manufacturing process and quality specifications prior to release.No rework or special conditions were reported.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 LOWER EXTR DRAPE 12
• Common Device Name: SURGICAL DRAPES AND PACKS
• Manufacturer (Section D): O&M HALYARD, INCL; 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
• MDR Report Key: 19094110
• Report Number: 3005997949-2024-00003
• Device Sequence Number: 7344340
• Product Code: PUI
• UDI-Device Identifier: 30680651423062
• UDI-Public: 30680651423062
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 42306
• Device Catalogue Number: 104230601
• Device Lot Number: AC2335402E
• Was Device Available for Evaluation?: Yes
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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