MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BIOCLUSIVE 6X7CM STERILE; FILM DRESSING

Model Number BIP0607

Device Problem Unsealed Device Packaging (1444)

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

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that product was discovered with the dressing trapped in the seal of the pouch.The actual device was not returned for evaluation.The manufacturing lot number and photographic evidence were provided for review.The dhr and analysis results were reviewed.All samples passed acceptance criteria.No non-conformance's were noted related to the reported issue.From the photo provided the issue was confirmed for product in seal.The parts are placed onto a packaging line by a guide feed system.If not properly setup, it leads to miss feeding of parts.Along with the guide there is a roller feed that guides the product placement, so the seals and cuts can be properly placed.If this location is not set properly it leads to parts in seal.Machine setup is manual that requires to be adjusted for each product.Therefore, the root cause is due to operator error and misaligned tooling.Operations team has been notified of the reported problems along with manufacturing engineers.Additionally, the ifu which is received with the product, along with the pouch label, identifies this failure mode with the symbol "do not use if package is damaged".This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised.Based on this information, no further action is required.Device not returned.

Event Description

Aspen surgical received a report from the distributor indicating that a bioclusive pouch was discovered with a seal issue.The item was not in use and no injury/death was reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: BIOCLUSIVE 6X7CM STERILE
• Type of Device: FILM DRESSING
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 8117158
• MDR Text Key: 128887734
• Report Number: 1836161-2018-00123
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BIP0607
• Device Lot Number: 169181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1