MalfunctionOTK
JP CHANNEL DRAIN SILICONE HUBLESS 15FR
Received May 29, 2022 · Event occurred Feb 1, 2022
Report 8030107-2022-00003 · MDR key 14538704
Device
Generic name
Jp Channel Drain Silicone Hubless 15fr
Manufacturer
Degania Silicone LtdModel number
15FRCatalog number
11003131580CR
Lot number
P2100072
Product problems
- Material Rupture
- Material Rupture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THERE WERE NO NON-CONFORMITIES DETECTED DURING THE BATCH HISTORY REVIEW AND TESTING OF THE RETAIN SAMPLE. THE DRAIN COULD TEAR DUE TO SOME DAMAGE IN USE. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED; NO CAPA WILL BE REQUIRED IN THIS CASE.
Description of Event or Problem
DRAIN FRACTURED UPON REMOVAL ON DAY OF PLANNED DISCHARGE. PATIENT RETURNED TO OPERATING ROOM ON SAME DAY TO TAKE OUT REMNANT.