Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED DRY/ WET LF; BOTTLE, COLLECTION, VACUUM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
Qn#: (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).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.Dhr shows that the product was assembled & inspected according to our specifications.The customer returned one a-6000-08lf (pe adult-ped dry/ wet lf) and tubing for investigation.During visual inspection, no obvious signs of damages were observed.The tubing was assembled correctly on each end of the ats connectors.The ats connectors were connected properly and no issues were observed that can lead to a leaking issue.The ats connector was disconnected to confirm the assembly of the o-ring and no damages were observed.Signs of use in the form of biological material were observed on the sample.Reference (b)(4) sample for image of sample as received.No corrective actions are required since the complaint cannot be confirmed at this time.The sample will be sent to nuevo laredo for further evaluation.The reported complaint of an "air leak at the red/blue connection(ats)" cannot be confirmed at this time.No damages were observed , and no leaks were detected upon investigation.The sample will be sent to nuevo laredo for further evaluation.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PE ADULT-PED DRY/ WET LF
Type of Device
BOTTLE, COLLECTION, VACUUM
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11567652
MDR Text Key242243887
Report Number3004365956-2021-00095
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 Received04/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-