MAUDE Adverse Event Report: COLOPLAST A/S IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE

Catalog Number BCHG64

Device Problems Insufficient Information (3190); Wrong Label (4073)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2023

Event Type  malfunction  

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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, the device did not match the labeling on the box.The wrong device model bchg64 was inside the box for the bcag64 device.No other adverse patient effects were reported.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and found none concerning lot number 9127011.However this issue was known, a labelling issue was occured concerning labelling and two lots are incriminated ( 9127010 and 9127011) a similar case study was performed based on this two item, bcag74 and bchg64 defect labelling.Five similar cases were found ( (b)(4) ).A resensibiilsation was already done with complaint previously registered about this lot number.Checking the quality databases revealed one corrective and preventive action and one non-conformity in relation to the described defect: - capa-00030 "quality improvement 2023/2024": all the operators of the distribution center were trained to good distribution practices in july 2023.- nc-003375 "kitting issues in lpp" opened on december 2023: the actions are ongoing.

Event Description

According to available information, the device did not match the labeling on the box.The wrong device model bchg64 was inside the box for the bcag64 device.No other adverse patient effects were reported.

• Brand Name: IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT
• Type of Device: UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17633232
• MDR Text Key: 322077627
• Report Number: 9610711-2023-00189
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 03600040982426
• UDI-Public: 3600040982426
• Combination Product (y/n): N
• PMA/PMN Number: K180469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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 Catalogue Number: BCHG64
• Device Lot Number: 9127011_BCHG643002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1