MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH CH14 TIEMANN

Model Number	2849401400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
This case concerns a (b)(6)-year-old male end user, who has been catheterizing since mid-(b)(6) 2020.On (b)(6) 2020, he experienced a major bleeding event upon catheterization with a sc tiemann catheter.He had made sure that the tiemann tip was pointing up during insertion, and that there were no sharp edges.There were no differences noticed during use when compared to the other sc tiemann catheters he had been using successfully in the previous weeks.He was hospitalized the next day ((b)(6) 2020).Flushing with saline was performed to thin out the blood clots he was experiencing, followed by surgery to cauterize a wound to stop the bleeding, which lasted about 12 hours (from the catheterization until the surgery).No infections were noted.It was stated that he had experienced a similar injury 2-3 weeks prior using a different manufacturers catheter.He was discharged from hospital on (b)(6) 2020 and is no longer using catheters.No additional information was provided.
Additional Manufacturer Narrative
A review of the production documentation did not find any non-conformances which could have lead to the reported issue.All returned samples met specification.A root cause for the reported issue could not be determined.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH CH14 TIEMANN
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11051066
• Report Number: 3006606901-2020-00018
• Device Sequence Number: 14196938
• Product Code: GBM
• UDI-Device Identifier: 05708932020404
• UDI-Public: 05708932020404
• Combination Product (Y/N): N
• PMA/510(K) Number: K023254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/03/2022
• Device Model Number: 2849401400
• Device Catalogue Number: 28494
• Device Lot Number: 7355007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR