TPLC - Total Product Life Cycle

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Device	apparatus, suction, patient care
Regulation Description	Patient care suction apparatus.
Product Code	DWM
Regulation Number	870.5050
Device Class	2

Premarket Reviews
Manufacturer	Decision
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCKET MEDICAL PLC
	SUBSTANTIALLY EQUIVALENT - KIT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	72	72
Adverse Event Without Identified Device or Use Problem	51	51
Fluid/Blood Leak	42	42
Fracture	30	30
Detachment of Device or Device Component	30	30
Sharp Edges	27	27
Material Puncture/Hole	24	24
Material Separation	23	23
Leak/Splash	18	18
Complete Blockage	17	17
Unsealed Device Packaging	14	14
Contamination	10	10
Device Handling Problem	10	10
Migration	10	10
Material Twisted/Bent	9	9
Crack	8	8
Product Quality Problem	8	8
Defective Component	6	6
Obstruction of Flow	6	6
Tear, Rip or Hole in Device Packaging	6	6
Improper or Incorrect Procedure or Method	5	5
Material Split, Cut or Torn	4	4
Device Dislodged or Dislocated	4	4
Packaging Problem	4	4
Device Markings/Labelling Problem	3	3
Separation Failure	3	3
Device Contamination with Chemical or Other Material	3	3
Disconnection	2	2
Restricted Flow rate	2	2
Suction Failure	2	2
Loose or Intermittent Connection	2	2
Difficult to Insert	2	2
Use of Device Problem	2	2
Device Appears to Trigger Rejection	2	2
Loss of or Failure to Bond	1	1
Device Contaminated at the User Facility	1	1
Mechanical Jam	1	1
Suction Problem	1	1
Missing Information	1	1
No Apparent Adverse Event	1	1
Decrease in Suction	1	1
Improper Flow or Infusion	1	1
Component Missing	1	1
Stretched	1	1
Air/Gas in Device	1	1
Patient Device Interaction Problem	1	1
Difficult to Remove	1	1
Expiration Date Error	1	1
Insufficient Information	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	348	348
Insufficient Information	41	41
No Consequences Or Impact To Patient	21	21
Unspecified Infection	16	16
Pneumothorax	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Pain	12	12
Foreign Body In Patient	10	10
Cellulitis	7	7
Peritonitis	7	7
Bacterial Infection	7	7
Discomfort	6	6
Pleural Empyema	4	4
Skin Inflammation/ Irritation	3	3
Ascites	3	3
Radiation Exposure, Unintended	2	2
Inflammation	2	2
Obstruction/Occlusion	2	2
Pleural Effusion	2	2
Skin Infection	1	1
Hypersensitivity/Allergic reaction	1	1
Sepsis	1	1
Vascular Dissection	1	1
Hematoma	1	1
Electrolyte Imbalance	1	1
No Known Impact Or Consequence To Patient	1	1
Skin Erosion	1	1
Erythema	1	1
Dyspnea	1	1
Pneumonia	1	1
Unspecified Respiratory Problem	1	1
Loss of consciousness	1	1
Cancer	1	1
Low Blood Pressure/ Hypotension	1	1
Decreased Respiratory Rate	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022