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	84	84
Adverse Event Without Identified Device or Use Problem	52	52
Fluid/Blood Leak	44	44
Detachment of Device or Device Component	32	32
Fracture	30	30
Sharp Edges	27	27
Material Puncture/Hole	25	25
Material Separation	22	22
Leak/Splash	22	22
Complete Blockage	19	19
Unsealed Device Packaging	16	16
Contamination	13	13
Device Handling Problem	13	13
Incomplete or Inadequate Connection	12	12
Migration	10	10
Crack	9	9
Material Twisted/Bent	9	9
Device Dislodged or Dislocated	8	8
Product Quality Problem	7	7
Tear, Rip or Hole in Device Packaging	6	6
Packaging Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Obstruction of Flow	5	5
Material Split, Cut or Torn	4	4
Defective Component	4	4
Device Contamination with Chemical or Other Material	3	3
Device Markings/Labelling Problem	3	3
Separation Failure	3	3
Difficult to Insert	2	2
Restricted Flow rate	2	2
Disconnection	2	2
Use of Device Problem	2	2
Loose or Intermittent Connection	2	2
Device Appears to Trigger Rejection	2	2
Difficult to Remove	2	2
Suction Failure	2	2
Improper Flow or Infusion	1	1
Connection Problem	1	1
No Apparent Adverse Event	1	1
Insufficient Device Problem Information	1	1
Patient Device Interaction Problem	1	1
Suction Problem	1	1
Decrease in Suction	1	1
Expiration Date Error	1	1
Malposition of Device	1	1
Loss of or Failure to Bond	1	1
Device Contaminated at the User Facility	1	1
Air/Gas in Device	1	1
Missing Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	395	395
Insufficient Information	44	44
No Consequences Or Impact To Patient	21	21
Unspecified Infection	16	16
Pneumothorax	16	16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	13	13
Pain	12	12
Foreign Body In Patient	11	11
Bacterial Infection	8	8
Cellulitis	7	7
Peritonitis	7	7
Discomfort	6	6
Pleural Empyema	4	4
Skin Inflammation/ Irritation	3	3
Pleural Effusion	3	3
Ascites	3	3
Obstruction/Occlusion	2	2
Inflammation	2	2
Radiation Exposure, Unintended	2	2
Erythema	1	1
Skin Infection	1	1
Loss of consciousness	1	1
Decreased Respiratory Rate	1	1
Device Embedded In Tissue or Plaque	1	1
Electrolyte Imbalance	1	1
Dyspnea	1	1
No Known Impact Or Consequence To Patient	1	1
Cancer	1	1
Vascular Dissection	1	1
Hematoma	1	1
Unspecified Respiratory Problem	1	1
Pneumonia	1	1
Sepsis	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Skin Erosion	1	1

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