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

Model Number	2858401400
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Blood Loss (2597)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the information received, the customer was prescribed 8fr catheters for use in voiding.A sample order was entered to ship samples of the 28578.The dc picked the order and shipped out the majority of the order as 28578 but there were inadvertently several 28584 (14fr) catheters that were included in the shipment.The customer did not notice that the french size was incorrect and attempted to use one of the 28584 (14fr) catheters.This resulted in trauma to the patient including bleeding in the urethra.The customer did not seek immediate medical attention.The customer subsequently used a sample of the 28578 (8fr) catheter later in the day and was able to void with no pain or bleeding.

• Brand Name: SPEEDICATH COMPACT CH14 FEMALE
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, DK-30 50; DA DK-3050
• MDR Report Key: 5943794
• Report Number: 3006606901-2016-00032
• Device Sequence Number: 13815842
• Product Code: GBM
• UDI-Device Identifier: 05708932020572
• UDI-Public: 05708932020572
• Combination Product (Y/N): N
• PMA/510(K) Number: K072808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2858401400
• Device Catalogue Number: 2858401400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2016
• Initial Report FDA Received Date: 09/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR