MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY 6F, MPD 90CM; PERCUTANEOUS CATHETER

Model Number	670-258-90
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, the tip of a 90cm 6f envoy catheter (67025890, 30157371) cracked.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr is to include the additional event information received on 4/26/2020.The additional event information resulted in a change in the reportability of this complaint.Therefore, it has been deemed not reportable.No further reports will be forthcoming.Section b5: additional information received indicated that there was a kinked and not a crack on the tip.Since no device has been received for analysis, no product investigation can be performed, and the reported failure could not be evaluated.A manufacturing record evaluation was performed for the finished device 30157371 number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: ENVOY 6F, MPD 90CM
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9986121
• Report Number: 3008114965-2020-00127
• Device Sequence Number: 3896370
• Product Code: DQY
• UDI-Device Identifier: 10886704031758
• UDI-Public: 10886704031758
• Combination Product (Y/N): N
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 10/31/2021
• Device Model Number: 670-258-90
• Device Catalogue Number: 67025890
• Device Lot Number: 30157371
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 04/26/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1