THORA-PARA NON-VALVED (OTP) CATHETER DRAINAGE SYSTEM
Received Feb 11, 2022 · Event occurred Dec 20, 2021
Report 1625685-2022-00028 · MDR key 13515759
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Hematoma
- Hemorrhage/Blood Loss/Bleeding
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Hematoma
- Hemorrhage/Blood Loss/Bleeding
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). (B)(4) 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 THORA-PARA NON-VALVED (OTP) CATHETER DRAINAGE SYSTEM CAUSED BLEEDING FROM PERITONEAL SITE, PERSISTENT LEAKAGE AT PERITONEAL INSERTION SITE, AND ABDOMINAL WALL HEMATOMA. VERBATIM: THORA-PARA NON-VALVED (OTP) CATHETER DRAINAGE SYSTEM; BLEEDING FROM PERITONEAL SITE ¿ 5; PERSISTENT LEAKAGE AT PERITONEAL INSERTION SITE ¿ 5; ABDOMINAL WALL HEMATOMA ¿ 2.