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: NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
  • 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
 

NULL PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Catalog Number C37101307J
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2020
Event Type  malfunction  
Event Description
It was reported that immediately after opening the package, the customer noticed no elbow connector was enclosed in it.No patient injury was reported.
 
Manufacturer Narrative
Other, a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.D4 udi is unknown.D5 operator of device is unknown.G2 manufacturing site address is unknown.G5 pma/510k is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PORTEX ANESTHESIA BREATHING CIRCUIT
Type of Device
CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section G)
NULL
MDR Report Key15416790
MDR Text Key299881793
Report Number3012307300-2022-19050
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date01/09/2023
Device Catalogue NumberC37101307J
Device Lot Number3895316
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-