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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX THORACIC CATHETERS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)?
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NULL PORTEX THORACIC CATHETERS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)? Back to Search Results
Catalog Number 200/812/160
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  Injury  
Event Description
It was reported that 3cm of the chest drain snapped off on removal and was left inside the patients chest cavity.Resulting in the patient having to have another general anesthetic and reopening of the wound to retrieve it.
 
Manufacturer Narrative
As per the pictures received for investigation, the pictures show the part snapped off on at the edge of one of the parts eye.Root cause cannot be defined at this time without the evaluation of the reported sample.Dhr shows no evidence of any defects during the manufacturing of the product.
 
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Brand Name
PORTEX THORACIC CATHETERS
Type of Device
TUBE, TRACHEOSTOMY (W/WO CONNECTOR)?
Manufacturer (Section G)
NULL
MDR Report Key13361220
MDR Text Key284507863
Report Number3012307300-2022-01807
Device Sequence Number1
Product Code BTO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number200/812/160
Device Lot Number4021907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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