MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH CH14 TIEMANN; INTERMITTENT CATHETER

Model Number	2849401400
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/24/2017
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.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.However, this case describes a user of intermittent catheters that was provided with a speedicath coudé catheter (bended tip) instead of a straight catheter.Catheter is ati on lead to significant bleeding, that necessitated placement of a foleycatheter and a subsequent visit to the emergency department as the bleeding persisted leading to blockage of the catheter some days later "the foley and bag got plugged up by the blood".The user is reported to have recovered and has been put back on intermittent catheter is at i on with straight catheters.The severity of the event is considered as 3, due to the amountand persistence of bleeding that indicates clinically significant urethral trauma.In addition, as no lot number is provided it is impossible to trace the relevant product documentation and check if similar faults were registered from the particular production lot.No additional complaints registered about this item no.Current month same issue.The complaints are monitored closely for a forming trend and reported to management on a monthly basis.Production has been informed.As no lot number is provided it is impossible to check the ncrs.As we have no received back any samples, the necessary tests cannot be made and can't confirm the issue.
Event or Problem Description
According to the available information, end user experienced a large amount of bleeding that he attributes to the speedicath coude.He was prescribed a straight tip but provided coude from the dr office.He ended up not being able to keep the speedicath coude pointed up and caused a large amount of bleeding.Urologist put him back on a foley.Days later, he ended up going to the e.R.Because the foley and bag got plugged up by the blood.Eu is back on straight speedicath after bleeding had stopped.Outcome: end user o longer experiencing bleeding.

• Brand Name: SPEEDICATH CH14 TIEMANN
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7182172
• Report Number: 3006606901-2018-00003
• Device Sequence Number: 16393226
• Product Code: GBM
• UDI-Device Identifier: 05708932020404
• UDI-Public: 05708932020404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

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 Model Number: 2849401400
• Device Catalogue Number: 2849401400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 01/11/2018
• 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: Other
• Patient Age: 70 YR