MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED WET LF 6/CS; BOTTLE, COLLECTION, VACUUM

Model Number	IPN028446
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We have had 3 cases in the last week in which we have identified a defect in the pleur-evac, no lot numbers or defective product a vailable.The is a defect at the junction of the rubber tubing to the corrugated tubing (red to blue connection).We have had to change out these 3 vacs for these patients within 24 hours post op.We have also completed fda form 3500.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.
Additional Manufacturer Narrative
Qn# (b)(4).The device history record of batch number 74m2101787 has been reviewed and no issues or discrepancies were found which could potentially relate 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.One unit of catalog number a-7000-08lf was received for analysis.The ats connector red & blue were received detached.The o-ring was visually inspected , and no damages were observed.The patient tubing with the ats connectors were connected to a source of air and was immerse under water.No bubbling's were observed that can confirmed a leak on ats connector.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
We have had 3 cases in the last week in which we have identified a defect in the pleur-evac, no lot numbers or defective product a vailable.The is a defect at the junction of the rubber tubing to the corrugated tubing (red to blue connection).We have had to change out these 3 vacs for these patients within 24 hours post op.We have also completed fda form 3500.

• Brand Name: PE ADULT-PED 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: 15138460
• Report Number: 3004365956-2022-00053
• Device Sequence Number: 12173842
• Product Code: KDQ
• UDI-Device Identifier: 34026704631279
• UDI-Public: 34026704631279
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2022

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: IPN028446
• Device Catalogue Number: A-7000-08LF
• Device Lot Number: 74M2101787
• 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: 07/30/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/24/2022
• 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
• Patient Sex: Unknown