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

Model Number	20767
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a distributor in japan: while they were operating, they opened a package and tried to put the product on the c-arm, something dropped.It was a part similar to one of the product parts.They initially thought it was the part came off the product they removed from the package and checked the product immediately.However, they found that nothing was missing from the product.The product was in perfect condition.They think an extra part got into the package with the product.
Additional Manufacturer Narrative
H3: the complaint product will not be returned.Therefore, this report is based solely on customer provided information.Historical complaint data review identified 2 other similar complaints for debris/dirt/ foreign material anywhere on product or packaging for this product family in the last 2 years.Based on sales data, this failure mode has a complaint rate of 0.003% during this time.The manufacturing process was reviewed and identified the most probable root cause to be related to human error during manufacturing or line clearance issue.Retraining was performed with the operators to prevent recurrence.This failure mode has a very low complaint rate, therefore no further corrective or preventative actions are necessary at this time.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: 2024-00702 h3 other text : product not returned.

• Brand Name: C-ARM EQUIPMENT COVERS CLEAR POLYETHYLENE
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• 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: 19796647
• Report Number: 2182318-2024-00088
• Device Sequence Number: 19867023
• Product Code: PUI
• UDI-Device Identifier: 01618125152208
• UDI-Public: 01618125152208
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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
• Device Model Number: 20767
• Device Catalogue Number: 20767
• Device Lot Number: 036854
• 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: 06/21/2024
• Initial Report FDA Received Date: 07/22/2024
• 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