UMBILICAL CATHETER
Received Aug 14, 2019 · Event occurred Jul 31, 2019
Report 2245270-2019-00053 · MDR key 8894428
Device
Product problems
- Migration
- Migration
Patient
Not reported
- Cardiac Tamponade
- Pericardial Effusion
- Cardiac Tamponade
- Pericardial Effusion
Narrative
Additional Manufacturer Narrative
THE FAILED SAMPLE WILL BE RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION. ALL UMBILICAL CATHETERS ARE 100% TESTED FOR TIGHTNESS AND NON-OBSTRUCTION DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINT HAS BEEN REGISTERED ON THE POSSIBLE LISTED BATCHES.
Description of Event or Problem
A CARDIAC ARREST ON TAMPONADE (PERICARDIAL EFFUSION) OCCURED THE (B)(6) 2019 , ON A PRETERM BABY. POSSIBLE BATCH: 240519PA, 200418AL, 220519PA OR 191018AL. NO FURTHER INFORMATION AVAILABLE CONCERNING THE PATIENT OUTCOME.
Additional Manufacturer Narrative
WE RECEIVED THE INVOLVED CATHETER .THE TUBE HAS BEEN CUT AT 15MM BEFORE THE MARKING OF 4 CM. WE NOTICED THAT THE CATHETER SHOWS CLEARLY SIGNS OF CUT AND TORN, CHARACTERISTIC OF A CUT MADE BY A SHARP OBJECT .IT OCCURS PROBABLY DURING THE PATIENT PLACEMENT. THE 3 POSSIBLE BATCHES ARE COMPLIANT TO THE SPECIFICATIONS .WE REGISTERED NO SIMILAR COMPLAINT ON THESE 3 POSSIBLE BATCHES.
Description of Event or Problem
A CARDIAC ARREST ON TAMPONADE (PERICARDIAL EFFUSION) OCCURED THE (B)(6) 2019 , ON A PRETERM BABY . POSSIBLE BATCH 240519PA ,200418AL ,220519PA OR 191018AL. NO FURTHER INFORMATION AVAILABLE CONCERNING THE PATIENT OUTCOME.