MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT CH10 FEMALE; INTERMITTENT CATHETER

Model Number 2858001624

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Based on the medical assessment regarding the relation of the catheter detachment to a fault in the product used should take into consideration the following: the force that is required to detach the top of the product from is base is significant, and the diameter of the base of the detached part is difficult to pass through the urethra without force.There are also unknown factors regarding the way the user handled the product, as she is currently reported to be hospitalised in a mental hospital for self-harm.The relationship between the event and a product fault is regarded as unlikely.However and based on a review of similar cases in 2017, further testing has been requested in order to finalise the assessment.In addition, checking the documentations - work order and shift report - from daily production indicated no deviations.The 18 pcs of returned/received samples from the same lot were tested for functionally and all of them were ok during the test.

Event Description

According to the available information, sccf 10fr top part removed in a cystoscopy procedure out of end-user bladder.A (b)(6) old woman suffers from neurogenic bladder and is using the product for the last two year.She was rushed to the hospital as the top part of the of the female compact cath was inside her bladder for no known reason.The part was removed in a cystoscopy procedure and patient was discharged.

• Brand Name: SPEEDICATH COMPACT CH10 FEMALE
• Type of Device: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S NYIRBATOR; coloplast utca 2; nyirbator, 4300 ; HU 4300
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6971705
• MDR Text Key: 90065197
• Report Number: 3006606901-2017-00021
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• PMA/PMN Number: K023254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2858001624
• Device Catalogue Number: 2858001624
• Device Lot Number: 4804381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR