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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA DR FOG TREATED SPONGE, STERILE; ANTI-FOG
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ASPEN SURGICAL PRODUCTS, CALEDONIA DR FOG TREATED SPONGE, STERILE; ANTI-FOG Back to Search Results
Model Number DF-3120
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2018
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the 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 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 complaint #(b)(4).
 
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 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 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 complaint # (b)(4).
 
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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
MDR Report Key7384760
MDR Text Key104261015
Report Number1836161-2018-00033
Device Sequence Number1
Product Code OCT
Combination Product (y/n)N
PMA/PMN Number
K932449
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberDF-3120
Device Lot Number137694
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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