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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED DRY/ WET LF; BOTTLE, COLLECTION, VACUUM
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TELEFLEX MEDICAL PE ADULT-PED DRY/ WET LF; BOTTLE, COLLECTION, VACUUM Back to Search Results
Model Number IPN028442
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual nor functional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.The device history record of batch number 74g2000459 that belong to catalog number a-6000-08lf (pe adult-ped dry/ wet lf) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to our specifications.The root cause is undetermined-no sample.The customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.However, material from the production line was verified and no issues were found that can lead to this customer complaint.If the sample becomes available this investigation will be updated with the evaluation results.Teleflex will continue to monitor and trend related events.
 
Event Description
The hospital faced 4 different incidents with 4 different pleur-evac.There was a leak at the level of letter "e" of the picture.It was bubbling at the "e" chamber despite a clamp (using "j" clamp) performed at the level between letters "i" and "l" on the tubing.Clinical consequence: the device was changed with success.It happened only with lot# 74g2000459.Additional information received: customer made an amendment about the location of the leak.Involved a patient who was in the thoracic surgery department because of an intervention by thoracotomy.The staff observed that there was a leak at the level of the red and blue ats connector.Clinical consequence: there was a delay in the treatment.There was no patient consequence.
 
Manufacturer Narrative
(b)(4).Complete sample was not returned to perform a proper investigation, just the ats connector section.A visual inspection of the product involved in the complaint was performed on ats connectors provided for analysis.No visual damage were found on the components that can lead to the issue reported.Air source (tfm-0060 nlc09684 due date 22-mar-22) was adapted and connected to section of sample received and ats connector was immerse into the water.No bubbles were observed, therefore the ats does not have leaks that can lead to the issue reported.No corrective action can be established since no problem found on sample.Customer complaint cannot be confirmed.Complete sample was not returned to perform a proper investigation, just the ats connector section.During functional test no leak on ats connector (p/n 152753) was found that can lead to the issue reported.
 
Event Description
The hospital faced 4 different incidents with 4 different pleur-evac.There was a leak at the level of letter "e" of the picture.It was bubbling at the "e" chamber despite a clamp (using "j" clamp) performed at the level between letters "i" and "l" on the tubing.Clinical consequence: the device was changed with success.It happened only with lot# 74g2000459.Additional information received: customer made an amendment about the location of the leak.Involved a patient who was in the thoracic surgery department because of an intervention by thoracotomy.The staff observed that there was a leak at the level of the red and blue ats connector.Clinical consequence: there was a delay in the treatment.There was no patient consequence.
 
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Brand Name
PE ADULT-PED DRY/ WET LF
Type of Device
BOTTLE, COLLECTION, VACUUM
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11567674
MDR Text Key248500425
Report Number3004365956-2021-00096
Device Sequence Number1
Product Code KDQ
UDI-Device Identifier34026704631231
UDI-Public34026704631231
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/06/2023
Device Model NumberIPN028442
Device Catalogue NumberA-6000-08LF
Device Lot Number74G2000459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2021
Date Manufacturer Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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