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

Model Number IPN028484

Device Problem Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2022

Event Type  malfunction  

Event Description

Pleurovacs have been noted to have bubbling in chamber.The system was exchanged for a new pleurovac and there was resolution of the issue, ruling out inappropriate seal on patients.

• Brand Name: PLEUR-EVAC
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 14110749
• MDR Text Key: 289274070
• Report Number: 14110749
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 14026704631664
• UDI-Public: (01)14026704631664(17)250105(10)74A2200227
• 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: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN028484
• Device Catalogue Number: S-1100-08LF
• Device Lot Number: 74A2200227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4380 DA
• Patient Sex: Female
• Patient Weight: 36 KG
• Patient Race: White