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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
In the emergency department and the pulmonology plant of the (b)(6) hospital it has been detected 6 times on 6 different patients since (b)(6) 2021 that the connection of the tube with the pleur-evac rubber is not watertight leading to the leaks in the chamber and event exit of pleural fluid trough the connection.This has generated errors in the diagnosis of the evolution of the patient's pulmonary pathology (detecting a non-real-leak) and causing late withdrawal of the thoracic tube, increasing the days of hospitalization, in addition to a possible risk of infection since not being properly sealed is a gateway to microorganisms.
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74c2100034 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.Manufacture date: (b)(6) 2021.Expiration date:2024-02-28 two representative samples of catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) lot 74c2100034 was received for analysis.Samples were received in they original packaging sealed.The ats connector (p/n 152753) were reviewed after functional test and no issues were observed.Two representative samples of catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) lot 74c2100034 was received for analysis.Samples were received in they original packaging sealed.The ats connector (p/n 152753) were reviewed after functional test and no issues were observed.Customer complaint cannot be confirmed.No leaks were observed on ats connector (p/n 152753) on representative sample received.
Event or Problem Description
In the emergency department and the pulmonology plant of the san pedro hospital it has been detected 6 times on 6 different patients since (b)(6) 2021 that the connection of the tube with the pleur-evac rubber is not watertight leading to the leaks in the chamber and event exit of pleural fluid trough the connection.This has generated errors in the diagnosis of the evolution of the patient's pulmonary pathology (detecting a non-real-leak) and causing late withdrawal of the thoracic tube, increasing the days of hospitalization, in addition to a possible risk of infection since not being properly sealed is a gateway to microorganisms.

• 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: 12507815
• Report Number: 3004365956-2021-00282
• Device Sequence Number: 19655551
• Product Code: KDQ
• UDI-Device Identifier: 34026704631668
• UDI-Public: 34026704631668
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• 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
• Report Date (Section B): 09/13/2021

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 Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1