MAUDE Adverse Event Report: BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS ACCESS; SYSTEM, IRRIGATION, UROLOGICAL

Catalog Number VMC4005

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a uromatic irrigation set was stuck in the welding of the packaging and could not be used.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.A visual inspection revealed inappropriate sealing traces on the packaging, and that the primary packaging was welded to the overpouch of each set.The cause of the condition was determined to be improper sealing method during assembly.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SYSTEM, IRRIGATION, UROLOGICAL
• Manufacturer (Section D): BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS; route de chebbaou; oued elil 2021 tn; tunis ; TS
• Manufacturer (Section G): BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS; route de chebbaou; oued elil 2021 tn; tunis ; TS
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4605086
• MDR Text Key: 5465272
• Report Number: 1416980-2015-11130
• Device Sequence Number: 1
• Product Code: LJH
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: VMC4005
• Device Lot Number: 14D30V030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Date Manufacturer Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1