MAUDE Adverse Event Report: COLOPLAST A/S SILIC FOLEY CATH 5/10ML /5; SILICONE FOLEY CATHETER

Model Number AA61141002

Device Problems Inflation Problem (1310); No Flow (2991)

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

Event Date 01/09/2016

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available - evaluation in progress.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 Description

According to the available information, problem at the level of the urinary catheter balloon that inflates in only one part.Several catheters tested , recurring problem.Balloon which does not inflate sufficiently and does not allow the urine to flow properly.Block problem occurred during a caesarean section - no clinical consequences.

Manufacturer Narrative

We received 4 sealed pouches printed aa6114 lot n°42553548 containing 2 ways folysil catheter with green valve printed "14-10ml-4255354".We inflated them with 12ml of sterile water and we noticed that they were all already asymmetric.We put them in simulation for 14 days.At the 14th day, we got them out and they remained inflated asymmetrically.We collected 11ml of water from the 12ml initially injected so they were all conform for lumen leakage and/or balloon deflation (as per en1616 annex d) we tested the water flow rate for all of them and it was on average 27.10l/h where our specification requires a minimum of 19l/h so they were all conform for their flow rate.However we consider the root cause of balloon asymmetry to be due to material.Our rmf criq216 identified the described risk as n°21413, 21414, 21415, 21616, 21623 and 21625 and it is in the green area which is considered acceptable.Based on the above this complaint is confirmed as a product defect.The balloon asymmetry issue for this product family is monitored on a monthly basis and it is 1ppm during the last 12 months which is considered acceptable compared to the threshold of 25ppm.

• Brand Name: SILIC FOLEY CATH 5/10ML /5
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING FRANCE SAS; 9 avenue edmond rostand; sarlat la caneda, 24206 ; FR 24206
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5419839
• MDR Text Key: 38330298
• Report Number: 9610711-2016-00005
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127360
• UDI-Public: 03600040127360
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/03/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2019
• Device Model Number: AA61141002
• Device Catalogue Number: AA61141002
• Device Lot Number: 4255354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Initial Date Manufacturer Received: 01/12/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1