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	07/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).One unit of catalog number a-7000-08lf (pe adult-ped wet lf 6/cs) lot 74e2200981 was received for analysis.Sample was received in its original packaging sealed.This is a representative sample with lot 74e2200981.After functional inspection the o-ring p/n 154589 was inspected and na dimensional inspection was not performed as part of this complaint investigation.No damages were observed.The tubing with the ats connector (p/n 152753) was disconnected from pe unit.One side of tubing was connected to a source of air (nlc09684 due:22-sep-23) and the other side was clamped.The ats connector was immerse into the water and no bubbles were observed that can confirmed a leak.The device history record of batch number 74e2200981 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 and inspected according to our specifications.No corrective action can be established since no problem found on sample.Customer complaint cannot be confirmed since no problem was found on sample.
Event or Problem Description
Air leak at the quick disconnect feature on the patient tubing.
Additional Manufacturer Narrative
Qn#(b)(4).One unit of catalog number a-7000-08lf (pe adult-ped wet lf 6/cs) lot 74e2200981 was received for analysis.Sample was received in its original packaging sealed.This is a representative sample with lot 74e2200981.After functional inspection the o-ring was inspected , and a dimensional inspection was not performed as part of this complaint investigation.No damages were observed.The tubing with the ats connector was disconnected from pe unit.One side of tubing was connected to a source of air and the other side was clamped.The ats connector was immerse into the water and no bubbles were observed that can confirmed a leak.The device history record 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 and inspected according to our specifications.No corrective action can be established since no problem found on sample.Customer complaint cannot be confirmed since no problem was found on sample.
Event or Problem Description
Air leak at the quick disconnect feature on the patient tubing.

• 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: 15218681
• Report Number: 3004365956-2022-00057
• Device Sequence Number: 17595386
• Product Code: KDQ
• UDI-Device Identifier: 34026704631279
• UDI-Public: 34026704631279
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/18/2022

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: 05/11/2025
• Device Model Number: IPN028446
• Device Catalogue Number: A-7000-08LF
• Device Lot Number: 74E2200981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2022
• 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