MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BIOCLUSIVE 10X12CM STERILE; FILM DRESSING

Model Number BIP1012

Device Problem Unsealed Device Packaging (1444)

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

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that a bioclusive pouch had product with seal issues.No injury/death was reported.A manufacturing lot number was available for evaluation.No sample or 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.With no sample or photo available, issue could not be confirmed.No further information is available on the product at this time.However, if a sample becomes available and any additional relevant information is identified following evaluation, any additional relevant information will be submitted in a supplemental report.Device not returned.

Event Description

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

• Brand Name: BIOCLUSIVE 10X12CM 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: 8252633
• MDR Text Key: 133332849
• Report Number: 1836161-2019-00006
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/21/2018

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 Model Number: BIP1012
• Device Lot Number: 165731
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2018
• 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