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	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Leaking at red/blue connector on (b)(4) different devices (prior to use on two different patients.The leak was found when initially connected to the patient.
Additional Manufacturer Narrative
Qn#(b)(4).The device has not been returned for investigation.
Event or Problem Description
Leaking at red/blue connector on 2 different devices (prior to use on two different patients.The leak was found when initially connected to the patient.
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74m2100579 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.No corrective action can be established at this moment since the product sample is not available for evaluation.Product sample is necessary to perform a proper investigation to determinate the root cause and the corresponding corrective actions.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.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.If defective sample becomes available at a later date this complaint will be updated as applicable.
Additional Manufacturer Narrative
(b)(4).One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) lot 74m2100579 was received for analysis.Sample wasn't received in its original packaging.After functional inspection the o-ring (p/n (b)(6)) was reviewed and no damages were observed.The tubing with the ats connector (p/n (b)(6)) was disconnected from pe unit.One side of tubing was connected to a source of air ((b)(6) 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.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
Leaking at red/blue connector on 2 different devices (prior to use on two different patients.The leak was found when initially connected to the patient.

• 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: 14674617
• Report Number: 3004365956-2022-00040
• Device Sequence Number: 4635946
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 06/06/2022

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: 12/08/2024
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74M2100579
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 06/15/2022; 08/03/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/11/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown