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

Model Number IPN028484

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event 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.

Event 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.

Manufacturer Narrative

Qn#(b)(4).Based on sample received, the device history record of batch number 74d2001314 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.One unit of catalog number s-1100-08lf (pe sahara dry suct/dry seal lf 6/cs) lot #74d2001314 was received for analysis.Sample was received in its original packaging sealed.After functional test, the oring p/n 154589 was inspected, and no issues were found that can lead to the issue reported.1.Suction port was connected to a suction source at 60 cm h2o and patient tube was put in warm water (with blue dye.Suction was activated and collection chambers were filled with water, during this test no leaks were observed on ats connector (p/n 152753).Equipment: emerson post-operative pump, nlc06976 2.The ats connector and tubing were removed form unit, one side of tubing was applied air pressure (10 psi, the other side was clamped and ats connector was immerse into the water.No bubbles were observed that can confirmed a leak on connectors.Equipment tfm-0060 nlc09684 due date: (b)(6) 2022.No problem found on sample.Customer complaint cannot be confirmed.No leaks were found on ats connector p/n 152753 on functional tests.

• Brand Name: PE SAHARA DRY SUCT/DRY SEAL LF 6/CS
• Type of Device: 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12507632
• MDR Text Key: 272513967
• Report Number: 3004365956-2021-00277
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631668
• UDI-Public: 34026704631668
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1