MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH CH12 TIEMANN

Model Number	2849201400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
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
According to available information, the complaint concerns an (b)(6) year-old male end user, who was a new user to catheters (has used catheters 7 times).On (b)(6) 2021, he experienced blood in the sc tiemann catheter (coudé) but did not feel any pain during catheterizing.The same night he started getting chills and called hcp.The hcp advised end user to come to the hospital.He was hospitalized for two days and a foley catheter was placed at the hospital.The hcp did not give the patient a definite answered what happened, but he did have a staff infection.The end user thinks he inserted the catheter too far up.At follow-up, it is stated that the end-user currently is not using catheters and no foley catheter was placed.It is not stated if the patient received medication to clear the infection.No other information was received.
Additional Manufacturer Narrative
17 closed samples of this lot were tested.All samples met production requirements.The quality engineer checked the manufacturing process related to the given finished goods lot number and no nonconformities were found that were related to this event.A review of the production documents did not reveal any non-conformity that are related to this event.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH CH12 TIEMANN
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11851347
• Report Number: 3006606901-2021-00015
• Device Sequence Number: 3748112
• Product Code: GBM
• UDI-Device Identifier: 05708932020398
• UDI-Public: 05708932020398
• Combination Product (Y/N): N
• PMA/510(K) Number: K180258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

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: 11/18/2022
• Device Model Number: 2849201400
• Device Catalogue Number: 28492
• Device Lot Number: 7762844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/14/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 80 YR