MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA +; POUCH, COLOSTOMY

Model Number 416416

Device Problems Break (1069); Burst Container or Vessel (1074)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Mdr 9618003-2019-05608 / device 1 of 1.(b)(4).

Event Description

The mother reports that ¿the top seam broke open, spilling fecal material onto the end user¿s central line.¿ it was reported by the mother that on the night of the event when she checked on the child at ¿9 o¿clock her bag was not full, at 10 o¿clock there was poop everywhere¿, ¿all over her chest, her arms, in her actual central lines." per the mother, the pouches are coming apart at the top and the side of the pouch and was previously reported.The mother states that the patient has ¿short bowl syndrome, so her stools are very watery".The mother was questioned on how the stool could have entered the central lines, per her report ¿she was receiving her infusion¿.The dressing gets changed ¿every 7 days,¿ it is unknown when the last dressing was applied.The dressing applied to the central line is a ¿standard central line dressing that is clear¿.When she noted the stool on the patient, her central line dressing was ¿soiled, the lines were soiled; the stool was under the dressing and in the lines".The mother states stool "must have entered where the iv lines connect to the central lines, since she was getting an infusion at the time".The child was then taken to the emergency room where blood cultures were obtained ¿one peripheral and one from the central line¿.The central line was in the child¿s ¿right upper chest¿.She reports that they were sent home but called back to the hospital today because the blood cultures were positive.The preliminary results reported grew both ¿gram negative and gram positive cocci¿.Once the final results had been released from the laboratory, it was requested the final culture result organism be obtained by the mother and reported.She could only report that ¿the doctor told me is that it is fecal matter growing¿.At the time of the report, the mother stated the child was ¿currently in icu, she has a pretty bad infection.¿ the initial course of treatment was reported to be ¿vancomycin, rocephin, and flagyl¿, but had been changed once the final culture results were received to a medication unknown.Per the mother, the patient is stable and would be in the children¿s hospital for ¿14 days with this new antibiotic¿.While in the hospital, the child had to be taken to ¿surgery for a new central line¿ due to the contamination of the line from the event.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

Correction (g1) - contact office address: (b)(6).Batch record review: lot 9g03059 was manufactured on 07/31/2019, in the aps 4 auto with a total of (b)(4) market units.All the components utilized were correct per bom and under icc code 416416, sap material id (b)(4) and manufacturing order (b)(4).The product was manufactured under device specification ds10-263, version 32.0.The product was packed and labeled under the packaging and labeling specification 1703524.The testing results were found satisfactory and the crew requirements and responsibilities, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according the process instructions pi31-091, version 7.0.Therefore, no discrepancy related to this issue were found within the documentation.Returned sample evaluation: there is no photograph associated with this case and no unused return sample was expected.Conclusion summary of the related event: after tools employed through this investigation and shown in this report, these were the findings and the opportunities identified: 1.Lack of spare parts, due to not being included in sap, because said were not listed in provided manual, and supplier timing or internal response.2.No change frequency stablished in pm, due to lack of detail in manufacturing line manual.3.Stablished teflon belt rotation not consider as critical at the manufacturing moment, as per interview to manufacturing personnel.4.Screw design has opportunities, being able to be replaced by clamps or self-tightening screws.5.Opportunities while tracking proper training of the maintenance personnel in this specific line.6.All tests were evaluated and they proved to detect these non-conformities.However, given the fact that product out of specifications is reaching the market, sampling plan must be strengthened in order to capture non-conformances.Actions will be taken for each factor and are going to be summarized on corrective action / preventive actions (capa) plan.Actions covered in this investigation will also be implemented in remaining aps automatic lines inside convatec d.R., except for aps1, because it¿s still under validation.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

• Brand Name: NATURA +
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 9221194
• MDR Text Key: 163301457
• Report Number: 9618003-2019-05608
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416416
• Device Lot Number: 9G03059
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1