MAUDE Adverse Event Report: TELEFLEX MEDICAL SAHARA PLEUR-EVAC DUAL ATRIUM CHEST TUBE; APPARATUS, AUTOTRANSFUSION

Model Number S-1102-08LF

Device Problem Leak/Splash (1354)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

Sahara pleur-evac dual atriums, lot number 74b2200790, experience significant air leak when attached to patient, replaced atrium with no resolution.Pt required transfer to single chest tube atrium.A 2nd pt was also impacted, therefore entire stock of lot number was pulled.Fda safety report id # (b)(4).

• Brand Name: SAHARA PLEUR-EVAC DUAL ATRIUM CHEST TUBE
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC 27560
• MDR Report Key: 14522181
• MDR Text Key: 292989466
• Report Number: MW5109961
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/25/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S-1102-08LF
• Device Lot Number: 74B2200790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Black Or African American