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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 C45041345-NLJ
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2020
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.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual inspection was performed and the sample was identified to have a tear 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 the anesthesia bag was noticed to be torn prior to the procedure.No patient injury was reported.
 
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Brand Name
PORTEX
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15414899
MDR Text Key306060996
Report Number3012307300-2022-19026
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 Catalogue NumberC45041345-NLJ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
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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