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

Catalog Number	S-1100-08LF
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not available for investigation.The device history record of batch number 74h1900492 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.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 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 the defective sample becomes available at a later date this complaint will be updated as applicable.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Per the customers complaint report a chest tube insertion was done on a patient.The chest tube was found to be leaking at the red blue connection site.Customer reported no visible signs of damage to tubing or connection site though pleural fluid dripping.A new pleur-evac chest tube draining system was attached to the chest tube which resolved the problem.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL LF 6/CS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10127929
• Report Number: 3004365956-2020-00113
• Device Sequence Number: 3636859
• Product Code: KDQ
• UDI-Device Identifier: 44026704428906
• UDI-Public: 44026704428906
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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: 08/02/2022
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74H1900492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1