MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA DR FOG TREATED SPONGE, STERILE; ANTI-FOG

Model Number DF-3120

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor that product was found in the seal of the pouch.The actual device was not returned for evaluation.The manufacturing lot number along with photographic evidence was also provided for review.The distributor indicated that the defect was found during incoming inspection.A review of the photos confirmed the issue from the distributor.Analysis of the finished good lot number 137694 was reviewed.No non-conformance's were noted during the manufacturing process.According to the manufacturing process, these parts are manually loaded into recessed pockets on a packaging machine per specified work instructions.If incorrectly loaded or not orientated properly, the product interferes with the sealing process.Therefore a likely root cause for the parts in the seal may be attributed to an operator error.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.Additionally, production supervisors were notified of this issue during the daily update meetings.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a dr fog sponge was found in the seal of the pouch.The item was not in use.No injury/death was reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: DR FOG TREATED SPONGE, STERILE
• Type of Device: ANTI-FOG
• 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: 7314055
• MDR Text Key: 101852262
• Report Number: 1836161-2018-00028
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K932449
• 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: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: DF-3120
• Device Lot Number: 137694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2017
• 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