MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH CH16 TIEMANN

Model Number	2849601400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hematuria (2558)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, this complaint is for a (b)(6) male end-user.The end-user is new to performing intermittent catheterizations.He had used the catheters for approximately 7 days with minor bleedings to begin with, which he was informed by his urologist was normal.On the (b)(6) he experienced more bleeding after catheterizing, went to the emergency room and was admitted to the hospital for 3 days, during which a foley catheter was inserted, and several bladder washouts was performed.The foley catheter was removed the (b)(6), and the urologist has encouraged the end-user to try and void on his own, but if this is unsuccessful, he should continue with the catheterizations.For now, he is voiding on his own and have a follow-up with his urologist later.The end-user was on blood thinner medication when the incident happened.The end-user had not noticed any damage to the catheter, or packaging.It is stated that the catheter was properly lubricated and no sharp edges.The-user confirms that he was trained in used the catheters correctly and states he used them correctly.
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.
Additional Manufacturer Narrative
E0506 hemorrhage bleeding has been added to annex e and uti has been removed.
Additional Manufacturer Narrative
The investigation of the quality engineer are as follows: ¿action(s) (correction(s), corrective and preventive): 1, the review of the production documents (coating and packaging process as well), the coa of the raw materials, the bioburden test results, and the sterilization coa.Based on the customer complaint the following investigation and conclusion was made: coating process: the product was manufactured on the ik19 machine.We have checked the following production documentation (work order, shift report, parameters sheet) based on the sampling plan, the following tests were performed on the products ((b)(4)version 27.0): ¿finger test (b)(4) version 5.0: under the test, we controlled the catheters from the tip to connector, in this way the hardening of the coating is tested and if there is areas with resistance or dry spots.¿friction test (b)(4) version 5.0 : under the test we investigated the friction force on the catheter surface ¿uncoated area measurement (b)(4) version 3.0: under the test we measured the uncoated catheter length: the part of the catheter that is not coated (the connector is not include).After the coating there is a 100% visual inspection on the machine and the non-conform catheters have been rejected by the operator.Production documentation have been reviewed and no issue was discovered during the production.All tests met the requirements.The process parameters were adjusted within validated process window.- packaging process: the product was packed on the machine hh4.The following documents were checked (work order, shift report, parameters sheet) based on the sampling plan, the following tests were performed on the products ((b)(4) version 27.0): ¿pressure test (b)(4) version 4.0: under the test we investigated the quality of the weld.¿manual peel test vv-0146835 version 5.0: under the test we testing three characteristics: dot sticks to the surface during opening, the packaging split/fray during opening, measurement of the width of the welding.¿corrosion test (b)(4) version 2.0: the corrosion test indicates if there are holes in the bottom foil, pe - peel layer.¿weight measure (b)(4) version 4.0; (b)(4) version 6.0: under the test the we investigated the weight of blister.So the product got the sufficient water dose.¿product appearance after the packing there is a 100% visual inspection on the hh4 machine and the non-conform catheters have been rejected by the operator.Production documentation have been reviewed and no issue was discovered during the production.All tests met the requirements.The bioburden test results and the coa of the sterilization was met the requirements.The incoming checked the raw material's coa and released the raw material for the production process.In summary, no deviation on the production's documentation was found.¿.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH CH16 TIEMANN
• 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: 12915761
• Report Number: 3006606901-2021-00034
• Device Sequence Number: 5719130
• Product Code: GBM
• UDI-Device Identifier: 05708932020411
• UDI-Public: 05708932020411
• 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,Followup
• Report Date (Section B): 02/11/2022

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: 08/04/2022
• Device Model Number: 2849601400
• Device Catalogue Number: 28496
• Device Lot Number: 7600785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/22/2021; 02/11/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/21/2022; 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male