MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 420591

Device Problem Fluid/Blood Leak (1250)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.A previous investigation covers all the issues of pinholes, partial weld, underweld, overweld on collar weld and pouch film separate from mass.The product was manufactured under device specification.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the process instructions.The process requirements results were documented in the product batch records and the product was packaged and labeled under the packaging and labeling specification.A non-conformance was generated to investigate the issue of pinholes, partial weld, underweld, overweld on collar weld and pouch film separating the from mass.No additional investigation is required.Additional information has been requested for patient/event details.Should additional information become available, a follow-up report will be submitted.Note: there is another case associated with this complaint.A separate 3500a form has been completed for the other case.(b)(4).

Event Description

It was reported by a hospital worker, that the pouch leaked while worn by a patient, resulting in a bacterial infection.It was also stated that this prolonged the recovery time for the patient.No further details have been provided.

Manufacturer Narrative

A batch record review indicates no discrepancies.A photograph has been received for this complaint and has been evaluated.Evaluation of the photograph reveals the product is a convatec product and is defective.This deficiency is covered under the nonconformance (nc) reported on the previous submission, mfr report #9618003-2016-00034, submitted to the fda on july 27, 2016.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on october 11, 2016.

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km 18.5; parque industrial itabo, s.a.; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5825644
• MDR Text Key: 50531710
• Report Number: 9618003-2016-00035
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2020
• Device Model Number: 420591
• Device Lot Number: 5B00547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention