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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS; BOTTLE, COLLECTION, VACUUM
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TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS; BOTTLE, COLLECTION, VACUUM Back to Search Results
Model Number IPN028484
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history record of batch number 74e2000906 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.
 
Event Description
Reported issue: incident occurred on (b)(6) 2022 in the pneumo- immuno allergology department.A pleur-evac drain was inserted in a patient suffering from a pleural effusion.When unclamping the tubing, pleural fluid went into the device, the doctor found a leak, and observed a crack in the tubing at the level of the clamp.There were no consequences for the patient.This is an isolated event.
 
Manufacturer Narrative
Qn#(b)(4).One unit of catalog number s-1100-08lf pe sahara dry suct/dry seal lf 6/cs lot 74e2000906 was received for analysis.Sample was not received in its original packaging, and it shows sign of usage.The tubing section where the ats connector (red connector) is was not received.No cracks were observed in the tubing where the blue connector is located.A tubing section with the red ats connector from regular production was connected to the sample received to perform a functional test.No leaks were observed.The device history record has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.No corrective action can be established since no problem found on sample.Customer complaint cannot be confirmed since no problem found on sample.
 
Event Description
Reported issue: incident occurred on (b)(6) 2022 in the pneumo- immuno allergology department.A pleur-evac drain was inserted in a patient suffering from a pleural effusion.When unclamping the tubing, pleural fluid went into the device, the doctor found a leak, and observed a crack in the tubing at the level of the clamp.There were no consequences for the patient.This is an isolated event.
 
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Brand Name
PE SAHARA DRY SUCT/DRY SEAL LF 6/CS
Type of Device
BOTTLE, COLLECTION, VACUUM
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
effie jefferson
3015 carrington mill blvd
morrisville 27560
9194332672
MDR Report Key16077738
MDR Text Key308531198
Report Number3004365956-2022-00121
Device Sequence Number1
Product Code KDQ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/15/2023
Device Model NumberIPN028484
Device Catalogue NumberS-1100-08LF
Device Lot Number74E2000906
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
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