MAUDE Adverse Event Report: TELEFLEX MEDICAL PLEUR-EVAC CHEST DRAINAGE SYSTEM; BOTTLE, COLLECTION, VACUUM

Model Number	IPN028442
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When the patient was reassessed later in the night, both nursing and patient could hear whistling that sounded like a leak from the tube.The connection site was checked between the pleur-evac and tube, the chest tube site was checked at the chest and were both fine.Leak could still be heard.The entire pleur-evac system was changed, the whistling sound then stopped, and the air leak also stopped.There must have been a hole somewhere in the pleur-evac tubing.Overnight, left chest tube placed to -40cmh20 and right side placed to -20cmh20.
Additional Manufacturer Narrative
(b)(4).The device history review shows that the product was assembled and inspected according to our specifications.No corrective action can be established at this moment since the product sample is not available for evaluation.
Event or Problem Description
When the patient was reassessed later in the night, both nursing and patient could hear whistling that sounded like a leak from the tube.The connection site was checked between the pleur-evac and tube, the chest tube site was checked at the chest and were both fine.Leak could still be heard.The entire pleur-evac system was changed, the whistling sound then stopped, and the air leak also stopped.There must have been a hole somewhere in the pleur-evac tubing.Overnight, left chest tube placed to -40cmh20 and right side placed to -20cmh20 ,.
Additional Manufacturer Narrative
Qn # (b)(4).One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74m2101785 was received for analysis.Sample wasn't received in its original packaging.It was observed one corner broken of pleur evac unit.The universal connector is broken also.No other issues were observed.Unit was connected to a suction source (nlc06976) to fill the collection chamber with blue water (55 cm h2o vac).No leaks were observed neither the "the whistling sound" was listened as complaint description says.In summary, customer complaint cannot be confirmed since no problem found on sample.No leaks nor "whistling sound" were perceived.

• Brand Name: PLEUR-EVAC CHEST DRAINAGE SYSTEM
• Common Device Name: 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15494763
• Report Number: 3004365956-2022-00071
• Device Sequence Number: 17606357
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2024
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74M2101785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male