MAUDE Adverse Event Report: TIDI PRODUCTS LLC OEC C-ARM EQUIPMENT COVERS CLEAR POLYETHYLENE STERILE; DRAPE, SURGICAL

Model Number	20767
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the complaint product is not available to be returned for evaluation.Therefore, this report is based on customer-provided information only.The device history record for this lot was reviewed and identified no nonconformances or other failures documented that could have contributed to the reported issue.All samples passed inspection prior to release.Historical complaint data review identified only one other similar complaint for this sku in the last 5 years, which was communicated along with this one by the same customer.This issue appears to be isolated to this manufacturing lot.The customer provided images of the complaint product that were shared with the manufacturing site and evaluated.Possible root cause was identified as damages for sealing area by external force during the manufacturing process.At this time, there is not enough evidence to confirm the root cause, but possible root cause is related to manufacturing error.The manufacturing site has been notified of the complaint for awareness and to prevent recurrence.No further corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference file (b)(4).
Event or Problem Description
It was reported by the customer: there are 2 qty defective items.Both have the same lot and the same expiration date.Details including lot numbers are as follows.1: the sterilization pack (cover) and the inner tube cover etc.Were sealed together.2: there was a lack of sealing, and when sealing, part of the product was chewed and sealed.Item#e9100ag lot# 033233 expiration date: 2027-11-12 total quantity of defective products:2 qty this file will address the second reported failure mode: "there was a lack of sealing, and when sealing, part of the product was chewed and sealed.".

• Brand Name: OEC C-ARM EQUIPMENT COVERS CLEAR POLYETHYLENE STERILE
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 17079358
• Report Number: 2182318-2023-00049
• Device Sequence Number: 13996531
• Product Code: KKX
• UDI-Device Identifier: 00618125152209
• UDI-Public: 00618125152209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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
• Device Model Number: 20767
• Device Catalogue Number: 20767
• Device Lot Number: 033233
• 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: 05/11/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown