Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BATRIK SOFTPACK ANTI-FOG SOLUTION W/SPONGE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASPEN SURGICAL PRODUCTS, CALEDONIA BATRIK SOFTPACK ANTI-FOG SOLUTION W/SPONGE Back to Search Results
Model Number 99-GOLFF
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2019
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 batrik anti-fog was found 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).
 
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was returned for evaluation.The manufacturing lot number along with samples were provided for review.The distributor indicated that the defects were found during incoming inspection.A review of the samples 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 defect 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 and operations were notified of this issue.Based on this information, no further action is required.
 
Event Description
Aspen surgical received a report from the distributor indicating that batrik anti-fog was found 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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BATRIK SOFTPACK ANTI-FOG SOLUTION W/SPONGE
Type of Device
ANTI-FOG
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
MDR Report Key9586569
MDR Text Key191438322
Report Number1836161-2020-00003
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 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number99-GOLFF
Device Lot Number209158
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-