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

Model Number	2841401400
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Blood Loss (2597)
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) male patient who has been taking blood thinners (10 mg) for about 10 years.The end user had been using the speedicath catheters for about 2 weeks or more.One night the catheter was unable to be inserted, so he re-tried the next day.The catheter was inserted, but upon removal black blood was observed in the catheter first, then urine, and then more blood.After using a diaper during the day as a precaution due to the bleeding he observed that the diaper was filled with blood.911 was called immediately.The patient was admitted to the hospital on (b)(6) and discharged on (b)(6).The patient was placed on a diaretic called furosemide in the hospital and fluid was taken from his stomach.The patient remains on this medication and is supposed to take 1 20g tablet a day for one month.After the incident, the blood thinner dosage was changed to 5 mg.The cause of the bleeding was undetermined; however, after an appointment with a urologist and placement of the patient on a foley catheter, the bleeding has stopped.No further bleeding episodes have occurred.No additional information was provided.
Additional Manufacturer Narrative
The device(s) were received for analysis.Analysis of the device(s) did not reveal any abnormalities or issues, the device(s) were within specification.Additionally, a review of the relevant production records did not find any non-conformances that could be related to the reported issue.
Additional Manufacturer Narrative
Patient and device codes omitted from initial report.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10528364
• Report Number: 3006606901-2020-00011
• Device Sequence Number: 3819221
• Product Code: GBM
• UDI-Device Identifier: 05708932020275
• UDI-Public: 05708932020275
• Combination Product (Y/N): N
• PMA/510(K) Number: K180258
• 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,Followup
• Report Date (Section B): 10/26/2020

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: 03/30/2022
• Device Model Number: 2841401400
• Device Catalogue Number: 2841401400
• Device Lot Number: 7397389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020; 10/13/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/12/2020; 10/26/2020
• 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