MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY DRAINAGE BAGS; INDWELLING CATHETER DRAINAGE COLLECT 78FCN

Model Number 37 452 0-10

Device Problems Partial Blockage (1065); Kinked (1339); Obstruction of Flow (2423)

Patient Problems Unspecified Infection (1930); Vomiting (2144); Organ Dehiscence (2502)

Event Date 05/02/2011

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury as it was potentially life threatening (risk of aspiration of emesis), and medical intervention has been required to treat wound infection.From a preliminary clinical perspective, a causal relationship between the urostomy drain bag and this event is deemed possible because the tubing was noted to be kinked.It is of note however, that the use of this product for collection of stomach contents from an ng tube is not an indication included in the labeling.A quality evaluation was conducted by third party manufacturer on (b)(4) 2011 based on the information received by the customer and sample received.One sample was received and tested, including visual inspection of the tube, and the test which showed how quickly the urine (according to intended use of the device) would have been drained into the bag according to strict international standard valid for this kind of medical equipment (iso 8669-2, 6.10) and we determined that it met our quality requirements.No deviations in connection with this issue were registered during the manufacturing process.No other complaints have been received on the batch, in addition a similar issue has been already investigated under a separate event identifier.Note: the actual date of event is unknown, so the date used was the date convatec became aware.Note: this mdr is being reported as a result of a retrospective review of complaints conducted by convatec for complaints received from (b)(4) 2013.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

Event Description

It is reported that the pouch was connected to a stomach tube, stop in the tube to the pouch (uropouchs tube).The pt was an unknown number of days post-op for a cystectomy.An ng tube was in place and it was connected to an unomedical urostomy pouch for passive drainage of stomach contents during the post op period.It was claimed that the "inlet tube" of the urine bag was blocked/kinked, causing an obstruction.The pt apparently vomited and thereafter the ng tub was removed.It is yet unknown if the ng tube was replaced after the vomiting ceased.It was discovered that the abdominal wound had dehisced "approximately 2x3 cm x 2 cm.Deep".The wound is reported to be infected and the pt is being treated with antibiotics.

• Brand Name: URINARY DRAINAGE BAGS
• Type of Device: INDWELLING CATHETER DRAINAGE COLLECT 78FCN
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer Contact: matthew walenciak, interim associ ; 200 headquarters park drive; skillman, NJ 08558 ; 9083779293
• MDR Report Key: 3788400
• MDR Text Key: 15877072
• Report Number: 3005778470-2014-00013
• Device Sequence Number: 1
• Product Code: FCN
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37 452 0-10
• Device Catalogue Number: 37 452 0-10
• Device Lot Number: 404951
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2011
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2011
• 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
• Patient Outcome(s): Required Intervention