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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED WET LF 6/CS; BOTTLE, COLLECTION, VACUUM
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TELEFLEX MEDICAL PE ADULT-PED WET LF 6/CS; BOTTLE, COLLECTION, VACUUM Back to Search Results
Model Number IPN028446
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 02/20/2023
Event Type  malfunction  
Event Description
It was reported that "the chest tube container was bubbling a large amount when applied to suction even when the tubing to the patient was clamped suggesting air entry into the container.There was no visible damage to the container.The container was changed for a new one and the bubbling slowed significantly.The new container also did not bubble when clamped".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
 
Manufacturer Narrative
Qn# (b)(4).Medwatch report #3901330000-2023-8011.Other remarks: n/a.Corrected data: n/a.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that "the chest tube container was bubbling a large amount when applied to suction even when the tubing to the patient was clamped suggesting air entry into the container.There was no visible damage to the container.The container was changed for a new one and the bubbling slowed significantly.The new container also did not bubble when clamped".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
 
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Brand Name
PE ADULT-PED WET 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
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key16833529
MDR Text Key314220954
Report Number3004365956-2023-00028
Device Sequence Number1
Product Code KDQ
UDI-Device Identifier34026704631279
UDI-Public34026704631279
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN028446
Device Catalogue NumberA-7000-08LF
Device Lot NumberLBL024289R01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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