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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
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MEDLINE INDUSTRIES LP CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT Back to Search Results
Catalog Number DYNCPDS14
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/28/2022
Event Type  Injury  
Event Description
It was reported that when suctioning the patient, the catheter became dislodged when pulling the catheter out of the endo tube with the suction on.The device was manually retrieved by the respiratory therapist with her fingers.
 
Manufacturer Narrative
It was reported that when suctioning the patient, the catheter became dislodged when pulling the catheter out of the endo tube with the suction on.The device was manually retrieved by the respiratory therapist with her fingers.The suctioning had to be terminated and a new catheter placed.The procedure was completed and the patient was stabilized.The respiratory therapist stated that the patient later passed away due to their current disease process not related to the reported event.No additional details are available related to the customer reported issue.A sample from a different lot was returned to the manufacturer for evaluation.It was reported that the catheter is separating from the thumb valve.The evaluation visually inspected the sample and found that the catheter is no longer attached to the thumb valve.The customer reported issue was confirmed, however a definitive root cause could not be determined.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
Manufacturer Narrative
Recall r-22-100 was initiated related to this issue.
 
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Brand Name
CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
Type of Device
CLEARPRO,CLOSED SXN,14FR,D SWVL,ETT
Manufacturer (Section D)
MEDLINE INDUSTRIES LP
three lakes drive
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
MDR Report Key15070900
MDR Text Key302868801
Report Number1417592-2022-00111
Device Sequence Number1
Product Code BSY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberDYNCPDS14
Device Lot Number06922010011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/28/2022
Initial Date FDA Received07/20/2022
Supplement Dates Manufacturer Received06/28/2022
Supplement Dates FDA Received07/27/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Removal/Correction NumberR-22-100
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age75 YR
Patient SexFemale
Patient Weight54 KG
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