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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL; PORTEX BREATHING CIRCUITS
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NULL; PORTEX BREATHING CIRCUITS Back to Search Results
Lot Number 4049351
Device Problems Material Puncture/Hole (1504); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2021
Event Type  malfunction  
Event Description
It was reported that immediately after opening the package, the customer found a pinhole in the product.No patient involvement reported.
 
Manufacturer Narrative
The device was received for evaluation.A device history record (dhr) review was performed which indicated all inspections were completed and no non conformances were identified during manufacture.Visual testing was performed and the reported issue was confirmed.A pinhole was observed on the device during visual inspection.The sample was found to be damaged/broke however; the root cause of the confirmed issue could not be determined.Manufacturing controls and instructions for use (ifu) are in place to help prevent occurrence of the reported issue.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
 
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Type of Device
PORTEX BREATHING CIRCUITS
Manufacturer (Section G)
NULL
MDR Report Key15427378
MDR Text Key305432015
Report Number3012307300-2022-19257
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 Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number4049351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2021
Was the Report Sent to FDA? No
Date Manufacturer Received07/09/2022
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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