TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, cholangiography
Regulation Description	Introduction/drainage catheter and accessories.
Product Code	GBZ
Regulation Number	878.4200
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	4	5
Device Contaminated During Manufacture or Shipping	3	3
Difficult to Advance	3	3
Fitting Problem	2	2
Component or Accessory Incompatibility	2	2
Material Split, Cut or Torn	2	2
Burst Container or Vessel	2	2
Insufficient Device Problem Information	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Separation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Device Contamination with Chemical or Other Material	2	2
Physical Resistance/Sticking	1	1
Material Puncture/Hole	1	1
Patient-Device Incompatibility	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Positioning Problem	1	2
Material Twisted/Bent	1	1
Sharp Edges	1	1
Delivered as Unsterile Product	1	1
Inadequacy of Device Shape and/or Size	1	5
Detachment of Device or Device Component	1	1
Activation Failure	1	1
Fracture	1	1
Loose or Intermittent Connection	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	30
Insufficient Information	6	7
Pneumothorax	4	4
Foreign Body In Patient	3	3
Pancreatitis	1	1
Perforation	1	1
Medical device site infection	1	1
Chest Pain	1	1
Pain	1	1