MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY DRAINAGE BAGS; KIT, URINARY DRAINAGE COLLECTION

Model Number 15 958 8-CURI

Device Problems Misassembled (1398); Incomplete or Missing Packaging (2312); Packaging Problem (3007)

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

Event Date 06/21/2011

Event Type  malfunction  

Event Description

Info ref.On the complaint report is stated as follows: "the wrong bags in the cartons, item 8027 should be included only 8019-370858-curi is packed in this box.(wrong product in box)".

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.There were no reports of the pt being harmed as a result of this malfunction.Final quality eval was conducted on (b)(4) 2011 based on the info provided by the customer and sample received which was one box with 25 pcs of bags.The box is marked with label (15 958 8-curi), inside the box there are bags of item (37 085 8-curi).Results are as follows: the sample was tested and did not perform to our requirements.An analysis to determine the potential root causes indicates that the mistake occurred during the packing process due to operator mistake, who most likely packed different type of bags into the inner boxes.The procedure for start-up and completion of the order "line clearance" concerning packaging and labeling was not followed.The results will be used to implement appropriate actions to prevent this issue from recurring.All relevant personnel who were packing the production order in question will be re-trained on line clearance procedure.Additionally, we have implemented strict rules for completing the order quantity of products in batch (e.G.Missing quantity due to increased waste).In conclusion, the appropriate personnel will be contacted to verify that products used for batch completion are in accordance with the specification and drawing.Note: this mdr is being reported as a result of a retrospective review of complaint records conducted by (b)(4) for complaints received from (b)(4) 2011 - (b)(4) 2013.Convatec will continue to track and monitor such complaints according to (b)(4) complaint handling and capa procedures.

• Brand Name: URINARY DRAINAGE BAGS
• Type of Device: KIT, URINARY DRAINAGE COLLECTION
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer Contact: matthew walenciak, director ; 200 headquarters park dr.; skillman, NJ 08558 ; 9083779293
• MDR Report Key: 3830007
• MDR Text Key: 4396767
• Report Number: 3005778470-2014-00020
• Device Sequence Number: 1
• Product Code: FCN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/21/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15 958 8-CURI
• Device Catalogue Number: 15 958 8-CURI
• Device Lot Number: 311041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2011
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2011
• Was Device Evaluated by Manufacturer?: Yes
• 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