MAUDE Adverse Event Report: STERILMED, INC.; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Catalog Number	DAI401860
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a procedure with a reprocessed ep catheter quad supreme cournand-2 and the inside package was not sealed.This was discovered when they went to open it.There was no damage, or any other issue observed on the external package of the device.There was no patient injury reported.
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by sterilmed inc., or its employees that the report constitutes an admission that the product, sterilmed inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure with a reprocessed ep catheter quad supreme cournand-2 and the inside package was not sealed.The related packaging or labeling was not returned for analysis.A non-sterile reprocessed daig ep catheter was received contained in a decontamination pouch.Upon receiving the device, visual inspection was conducted, and it was observed that the catheter was returned with no apparent damage.The device was received with a serial number label still attached.The noted serial number is (b)(6).This serial number is linked to lot 2204339, which had only been reprocessed one time.The described event could not be confirmed since the involved packaging was not returned or received for analysis.There is no evidence that any of the materials received by the customer had not been sealed or that the sterility had been compromised.As part of sterilmed's quality process, all devices are manufactured, inspected, and released to approved specifications.All devices, reprocessed under lot 2204339, underwent 100% inspection at different points during the manufacturing process to prevent issues such as reported from leaving the facility.The device history record was reviewed, and the device had passed its final finished goods inspection and quality check prior to being distributed to the customer.A manufacturing record evaluation was performed for the finished device lot number 2204339, and no internal actions or manufacturing irregularities related to the malfunction were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: NA
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19779320
• Report Number: 2134070-2024-00015
• Device Sequence Number: 15492305
• Product Code: NLH
• UDI-Device Identifier: 10888551008686
• UDI-Public: (01)10888551008686(11)240312(17)250312(10)2204339
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K012678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Expiration Date: 03/12/2025
• Device Catalogue Number: DAI401860
• Device Lot Number: 2204339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown