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

Model Number	IPN028484
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74e2000906 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.
Event or Problem Description
Reported issue: incident occurred on (b)(6) 2022 in the pneumo- immuno allergology department.A pleur-evac drain was inserted in a patient suffering from a pleural effusion.When unclamping the tubing, pleural fluid went into the device, the doctor found a leak, and observed a crack in the tubing at the level of the clamp.There were no consequences for the patient.This is an isolated event.
Additional Manufacturer Narrative
Qn#(b)(4).One unit of catalog number s-1100-08lf pe sahara dry suct/dry seal lf 6/cs lot 74e2000906 was received for analysis.Sample was not received in its original packaging, and it shows sign of usage.The tubing section where the ats connector (red connector) is was not received.No cracks were observed in the tubing where the blue connector is located.A tubing section with the red ats connector from regular production was connected to the sample received to perform a functional test.No leaks were observed.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 found on sample.
Event or Problem Description
Reported issue: incident occurred on (b)(6) 2022 in the pneumo- immuno allergology department.A pleur-evac drain was inserted in a patient suffering from a pleural effusion.When unclamping the tubing, pleural fluid went into the device, the doctor found a leak, and observed a crack in the tubing at the level of the clamp.There were no consequences for the patient.This is an isolated event.

• 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: 16077738
• Report Number: 3004365956-2022-00121
• Device Sequence Number: 12335905
• Product Code: KDQ
• UDI-Device Identifier: 34026704631668
• UDI-Public: 34026704631668
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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: 05/15/2023
• Device Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74E2000906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• 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; NONE REPORTED
• Patient Sex: Unknown