TPLC - Total Product Life Cycle

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Device	tube, nasogastric
Regulation Description	Gastrointestinal tube and accessories.
Product Code	BSS
Regulation Number	876.5980
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	12	12
Material Split, Cut or Torn	9	9
Suction Failure	8	8
Partial Blockage	6	6
Decrease in Suction	4	4
Disconnection	4	4
Component Misassembled	4	5
Insufficient Device Problem Information	3	3
Incorrect Measurement	3	4
Material Fragmentation	2	2
Device Contamination with Chemical or Other Material	2	2
Device Handling Problem	2	2
Component Missing	2	3
Separation Failure	2	2
Nonstandard Device	2	2
Inaccurate Information	2	2
Unclear Information	2	2
Burst Container or Vessel	1	1
Complete Blockage	1	1
Inaccurate Flow Rate	1	1
Fracture	1	1
Difficult to Insert	1	1
Material Twisted/Bent	1	1
Material Too Soft/Flexible	1	1
Fitting Problem	1	2
Defective Component	1	1
Malposition of Device	1	1
Material Puncture/Hole	1	1
Material Rupture	1	1
Wrong Label	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	70	72
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	5	5
Vomiting	3	3
Insufficient Information	3	3
Bradycardia	2	2
Pneumoperitoneum	2	2
Airway Obstruction	2	2
Foreign Body In Patient	2	2
Hemorrhage/Blood Loss/Bleeding	1	1
Adult Respiratory Distress Syndrome	1	1
Perforation	1	1
Hematemesis	1	1
Low Blood Pressure/ Hypotension	1	1
Skin Discoloration	1	1
Discomfort	1	1
Laceration(s)	1	4
Hyperglycemia	1	1
Perforation of Esophagus	1	1
Low Oxygen Saturation	1	1
Unspecified Kidney or Urinary Problem	1	1
Hypoxia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	C.R. Bard Inc	II	Jan-25-2024