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

Model Number	2841401400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Exsanguination (1841)
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 the available information, this complaint describes a (b)(6) -year-old male end-user who was using speedicath standard intermittent catheter for a catheterisation.He had used about 15 catheters, the others without problems, but with the last one he experienced bleeding, for which he needed treatment at the emergency room.The end-use describes that he inserts the catheter slowly on both the insertion and on the way out of the urethra, but when inserting this last catheter, he felt like he had to push the catheter hard to get it into the bladder.He felt pain after a while.The amount of blood is stated to be measured by the end-user him-self to about 2 liters.The end-user was at the hospital for about an hour and an indwelling catheter (foley catheter) was placed.He will see his medical doctor soon and keep the indwelling catheter until further notice.The end-user states that this is the third time he is being prescribed intermittent urinary catheters and the previous attempts with intermittent catheter did also result in bleeding and an indwelling catheter, but the bleeding at this incident was worse than the previous events.The end-user states that the catheters were properly lubricated, he added additional lubrication himself and the catheters did not feel sharp or rough nor was the packaging damaged.
Additional Manufacturer Narrative
In section h, it has been changed that the device is "not returned to manufacturer".Annexes b, c, d have been changed to reflect device not returning.Samples have not been returned for sampling.The relevant production documentation was checked in the database and nonconformity was not revealed, that could be related to the described issue.As samples were not available for testing and the reviewed production documents did not reveal any norm deviation about this lot that could be related to the described issue, this complaint cannot be verified.Quality engineer of the area has also checked the manufacturing process related to the given finished good lot number and no nonconformity was found that could cause this case.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH CH14 MALE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13059731
• Report Number: 3006606901-2021-00036
• Device Sequence Number: 1506064
• 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
• 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): 02/15/2022

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: 07/28/2022
• Device Model Number: 2841401400
• Device Catalogue Number: 28414
• Device Lot Number: 7590730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male