MAUDE Adverse Event Report: TELEFLEX INCORPORATED PLEUR-EVAC SAHARA; BOTTLE, COLLECTION, VACUUM

Catalog Number S-1100-08LF

Device Problems Leak/Splash (1354); Defective Device (2588)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

Sahara chest tube canister defective/leaking.Resolved with new sahara.Ref: s-1100-08lf, lot: 74m2201538.

• Brand Name: PLEUR-EVAC SAHARA
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 17162229
• MDR Text Key: 317467715
• Report Number: 17162229
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2023

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
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74M2201538
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Male