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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 200602
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
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.Visual inspection was performed.The sample was found to be in used condition, without its original packaging, and the elbow connector was missing.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 upon opening the package the elbow connector was found not attached to the product.No patient injury was reported.
 
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Brand Name
PORTEX
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section G)
NULL
MDR Report Key15415117
MDR Text Key306076215
Report Number3012307300-2022-19039
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number200602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/07/2022
Initial Date FDA Received09/13/2022
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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