MAUDE Adverse Event Report: COLOPLAST A/S PED FOLYSIL CATH 1.5ML CH06/5; SILICONE FOLEY CATHETER

Model Number	AA61061002
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint on this lot.Checking the quality databases revealed no anomaly in connection with the described defect.On 29jan we received 1 used bloody sample and decontaminated it with anioxyde 1000 - we see the mandrel out of the catheter by the eyelet according the ifu sh2115 : instructions for use : n.B.Prior the catheterisation it is usual practice to check that the valve and balloon are functioning properly by inflating and then deflating the balloon.Warning : pediatric catheters of diameters 06.08 and 10ch may include a stylet that facilities their insertion before insertion : make sure that the stylet can move in the catheter and examine the end of the catheter to ensure that the stylet is positioned perfectly inside the catheter and does not comes out of an eye.Based on the above, this complaint is not confirmed as a product defect.
Event or Problem Description
According to the available information, nothing different was noticed about the catheter.The catheter was inserted a couple of millimeters, some resistance was felt and the catheter couldn't be inserted further.The catheter was removed immediately and a few drops of blood was visible.A small stomach probe was inserted and that stopped the bleeding.Baby is doing well.

• Brand Name: PED FOLYSIL CATH 1.5ML CH06/5
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8353195
• Report Number: 9610711-2019-00008
• Device Sequence Number: 2198557
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 03600040126844
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2019

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: Health Professional
• Device Model Number: AA61061002
• Device Catalogue Number: AA6106
• Device Lot Number: 5854765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/20/2019
• 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