MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED DRY/ WET LF 6/CS; 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	07/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Incident happened in the resuscitation department.On (b)(6) 2022.Involved a female patient.We observed on the x-ray that there was a discrepancy between the patient whose pneumothorax was solved with success and the pleur-evac that was still bubbling.We believe there is a leak at the level of the tubing between the blue ats connector and the water filled suction column.The consequence was a delay in the department.We still changed the pleur-evac and the new pleur-evac was not bubbling.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74h2101633 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance 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.(1) unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74h2101633 was received for analysis.Sample wasn't received in its original packaging.The red ats connector was not received.A tubing with the red ats connector from production line was used on the sample to perform suction and observe if there is a leak on the tubing as mentioned on complaint description "a leak at the level of the tubing between the blue ats connector and the water filled suction column".The unit was connected to a source of air and unit was filled with blue water.During and after this test no leaks were observed.In summary, no corrective action can be established since no problem found on sample.Customer complaint cannot be confirmed since no problem found on sample.
Event or Problem Description
Incident happened in the resuscitation department.On 27 july 2022.Involved a female patient.We observed on the x-ray that there was a discrepancy between the patient whose pneumothorax was solved with success and the pleur-evac that was still bubbling.We believe there is a leak at the level of the tubing between the blue ats connector and the water filled suction column.The consequence was a delay in the department.We still changed the pleur-evac and the new pleur-evac was not bubbling.

• Brand Name: PE ADULT-PED DRY/ WET LF 6/CS
• 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: 15139037
• Report Number: 3004365956-2022-00054
• Device Sequence Number: 20234212
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 08/21/2024
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74H2101633
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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
• Patient Sex: Unknown