MAUDE Adverse Event Report: TELEFLEX MEDICAL PE SAHARA DRY SUCT/DRY SEAL LF 6/CS; BOTTLE, COLLECTION, VACUUM

Model Number	IPN028484
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).A photograph of the sample related with this complaint was received for analysis.In such photograph, it was observed the patient tube with the blue connector from the ats connector.No issues were observed.The device history record of batch number 74j2201076 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.The device history record 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.The 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 co mplaint.If defective sample becomes available at a later date this complaint will be updated as applicable.
Event or Problem Description
Reported issue: an air leak was detected.The blue connector seemed loose when connected to tubing coming from the patient.Switched out for another unit using same tubing coming from patient and air leak went away.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL 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: 16447870
• Report Number: 3004365956-2023-00010
• Device Sequence Number: 17607457
• Product Code: KDQ
• UDI-Device Identifier: 34026704631668
• UDI-Public: 34026704631668
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: 09/14/2025
• Device Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74J2201076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown