MAUDE Adverse Event Report: AESCULAP INC. AESCULAP; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number	MD344
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that there were pinholes in the filter.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).One (1) md344 round filter polypropylene sample provided was sent to the manufacturing site for evaluation and the results of the investigation confirmed that there was red splice tape present on the sample.The red tape is an indication of spliced raw material.The device quality and manufacturing history records (dhr) review found the device was manufactured according to specification.Based on the investigation findings, the root cause is manufacturing related.The manufacturing site is aware of this issue and has entered this complaint into our trending report.
Additional Manufacturer Narrative
The adverse event is filed under aic reference (b)(4).Additional information: d4.Expiration date.Correction: d4.Udi number corrected.

• Brand Name: AESCULAP
• Common Device Name: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: elena reifenstein ; 3773 corporate parkway; center valley, PA 18034 ; 8334251464
• MDR Report Key: 22306758
• Report Number: 2916714-2025-00038
• Device Sequence Number: 7925354
• Product Code: KCT
• UDI-Device Identifier: 14522281506819
• UDI-Public: (01)14522281506819(17)271130(10)2411103
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K093493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2026

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: MD344
• Device Catalogue Number: MD344
• Device Lot Number: 2411103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/12/2025; 03/24/2026
• 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