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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX; ANESTHESIA CONDUCTION KIT
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NULL PORTEX; ANESTHESIA CONDUCTION KIT Back to Search Results
Lot Number 200825
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
Catalog number is unknown.Udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.Remarket (510k) number is unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.The sample was received in used condition without its original packaging.Visual inspection confirmed the breathing bag has a tear.Unable to determine the root cause of the reported issue.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
Event Description
It was reported that a pinhole was found in the breathing bag upon opening the package.No patient injury was reported.
 
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Brand Name
PORTEX
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15414921
MDR Text Key306061970
Report Number3012307300-2022-19028
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number200825
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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