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	09/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer mentioned that the clinical staff heard a hissing noise (potential air leak) at the site of the quick disconnect.Additional information indicates that the noise was coming from the red/blue connection.
Additional Manufacturer Narrative
(b)(4).A visual, dimensional, or functional inspection of the product involved in the complaint could not be conducted since the product was not returned.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.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.Product sample is necessary to perform a proper investigation to determine 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 nor is being manufactured at the time.If the sample becomes available this investigation will be updated with the evaluation results.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15469631
• Report Number: 3004365956-2022-00069
• Device Sequence Number: 11471265
• 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
• Report Date (Section B): 09/02/2022

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/23/2022
• 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