THORA-PARA VALVED (TPT)
Received Jan 13, 2022 · Event occurred Dec 20, 2021
Report 1625685-2022-00008 · MDR key 13254346
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Bacterial Infection
- Bruise/Contusion
- Hematoma
- Low Blood Pressure/ Hypotension
- Great Vessel Perforation
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Bacterial Infection
- Bruise/Contusion
- Hematoma
- Low Blood Pressure/ Hypotension
- Great Vessel Perforation
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
(B)(6). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). (B)(6). FOLLOW-UP EMDR FOR DEVICE EVALUATION: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT PERSISTENT LEAKAGE AT PERITONEAL INSERTION SITE :100, ABDOMINAL WALL HEMATOMA:100, INFECTION FOLLOWING PARACENTESIS:100, HYPOTENSION FOLLOWING PARACENTESIS:100 , PERFORATION OF SURROUNDING VESSELS OR VISCERA :100, AND SOFT TISSUE INJURY:100. THORA-PARA VALVED (TPT) CATHETER DRAINAGE SYSTEM: RE-EXPANSION PULMONARY EDEMA :50, PNEUMOTHORAX:40, HEMOTHORAX :20, LACERATION OF LUNG OR LEVER : 40, HYPOTENSION/CIRCULATORY COLLAPSE:100, INFECTION FOLLOWING THORACENTESIS :100, EMPYEMA AND INFECTION IN THE PLEURAL CAVITY :100, BLEEDING FROM PERITONEAL SITE :100, POST-PARACENTESIS CIRCULATORY DYSFUNCTION:100 , PERSISTENT LEAKAGE AT PERITONEAL INSERTION SITE :100, ABDOMINAL WALL HEMATOMA : 100, INFECTION FOLLOWING PARACENTESIS : 100, HYPOTENSION FOLLOWING PARACENTESIS : 100 , PERFORATION OF SURROUNDING VESSELS OR VISCERA : 100, AND SOFT TISSUE INJURY :100.