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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
Catalog Number 670012
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
Udi information is unknown.Operator of device is unknown.No information has been provided to date.Manufacturing site address is unknown.Premarket (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 a hole in the breathing bag.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 hole in the breathing bag was found during pre-use check.No patient injury was reported.
 
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Brand Name
PORTEX
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15437116
MDR Text Key306079790
Report Number3012307300-2022-19415
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 09/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date07/28/2021
Device Catalogue Number670012
Device Lot Number3662737
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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