MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING; DRESSING,WOUND,OCCLUSIVE

Model Number 187955

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2019-04786 / device 1 of 2.Initial reporter: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported ¿there was a red line mark on the package¿.The product was not used on or by a patient.Photographs depicting the reported complaint issue were provided by the complainant.

Manufacturer Narrative

(b)(6).Batch record review: lot 9a05273y was manufactured on 01/29/2019 in the bodolay line with a total of (b)(4) market units.Complaint investigator id 5173 performed a batch record review on 11/23/2020 to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct, under icc code 187955 sap material id 1704768 and manufacturing order 1453575.The batch record review supports that there were no discrepancies related to the issue reported.Returned sample evaluation: photo related to the reported problem is available for evaluation.Investigation summary: brief description of issue: this root cause investigation has been generated due to a trend on non-conformances related to sealing failure modes at the bodolay pratt c building 8a, that as per tm-002 ver 13.0 are not acceptable.The bodolay pratt line in convatec haina facility has had 4 non-conformance lots related to sealing.The lots had incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination (e.G.Water marks, stains), or dressing or loose material is trapped in packaging, with a severity rating of 4 for product lots 0e02593, 0e00555, 0e01787 and 0e03600 were affected by defects in the product sealing.According with the tm-002 (package seal integrity nonconformities) ver 13.0 and dr-sop-0063 (quality inspection plan) ver 20.0, chevron pouch with defective sealing is not acceptable.Based on the investigation¿s findings using the 6 m¿s methodology and through revision of the batch records documentation, process observation, personnel interviewed, methodology implemented, the root cause for this was identified as machine.As observed during this investigation the contributor factor to this failure mode were: root cause(s) solution(s).Lot 0e02593 (seal width < 3mm): due to worn down on the indexation wheels, the indexation process was not being performed properly which caused the paper to slip through the wheels and reduced the overall tension on the process, that along with the type of dressing (cgf, it doubles the extra thin dressing in size and weight) increased the risk for the dressing sub-assembly to move within the limits of the chevron, affecting the sealing width on its way preventive maintenance review to establish a frequency of replacement and verification that meets the requirements per product family.Set-up process will be established for the sealing station.Lot 0e00555 (open seal): due to wear down on the cutter blades, the blisters were being opened after the sealing process on the tyvek area.Lot 0e03600 (open seal): it was identified that one of the screws holding the pressure cylinder and the upper sealing plate was not in good condition.Update the weekly plan to include the red rubber verification and cutter blades verification.Set-up process will be established for the sealing station.Lot 0e01787 (channel in the seal): it was identified that the red rubber used on the sealing station was not in proper conditions, the zone 2 red rubber had areas that were not leveled which caused channels in the seal due to an incomplete transference of heat from the upper sealing and the lower sealing.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1 049092.Manufacturing site: 9618003.

Event Description

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

• Brand Name: DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• MDR Report Key: 8888503
• MDR Text Key: 154144443
• Report Number: 9618003-2019-04786
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2024
• Device Model Number: 187955
• Device Lot Number: 9A05273Y
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1