TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
BEARPAC MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
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	66	66
Material Separation	55	55
Adverse Event Without Identified Device or Use Problem	47	47
Fluid/Blood Leak	45	45
Fracture	36	36
Leak/Splash	35	35
Detachment of Device or Device Component	32	32
Sharp Edges	27	27
Material Puncture/Hole	19	19
Complete Blockage	13	13
Unsealed Device Packaging	13	13
Tear, Rip or Hole in Device Packaging	10	10
Material Split, Cut or Torn	9	9
Device Handling Problem	8	8
Material Twisted/Bent	8	8
Obstruction of Flow	7	7
Defective Component	6	6
Device Dislodged or Dislocated	6	6
Migration	5	5
Product Quality Problem	4	4
Crack	4	4
Contamination	4	4
Device Contamination with Chemical or Other Material	3	3
Difficult to Remove	3	3
Separation Failure	3	3
Device Markings/Labelling Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Defective Device	2	2
Appropriate Term/Code Not Available	2	2
Component Misassembled	2	2
Difficult to Insert	2	2
Use of Device Problem	2	2
Component Missing	2	2
Loose or Intermittent Connection	2	2
Patient-Device Incompatibility	2	2
Suction Failure	2	2
Decrease in Suction	2	2
Restricted Flow rate	2	2
Suction Problem	1	1
No Apparent Adverse Event	1	1
Mechanical Jam	1	1
No Flow	1	1
Loss of or Failure to Bond	1	1
Packaging Problem	1	1
Material Deformation	1	1
Infusion or Flow Problem	1	1
Improper Flow or Infusion	1	1
Gas/Air Leak	1	1
Stretched	1	1
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	280	280
No Consequences Or Impact To Patient	98	99
Insufficient Information	34	34
Pneumothorax	18	18
Unspecified Infection	15	15
Pain	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Foreign Body In Patient	11	11
No Code Available	9	9
No Known Impact Or Consequence To Patient	8	8
Cellulitis	7	7
Discomfort	5	5
Peritonitis	5	5
Pleural Empyema	3	3
No Information	3	3
Radiation Exposure, Unintended	3	3
Skin Inflammation	3	3
No Patient Involvement	3	3
Bacterial Infection	3	3
Inflammation	2	2
Obstruction/Occlusion	2	2
Irritation	2	2
Death	2	2
Pressure Sores	2	2
Device Embedded In Tissue or Plaque	2	2
Skin Inflammation/ Irritation	1	1
Adhesion(s)	1	1
Pulmonary Emphysema	1	1
Hematoma	1	1
Blood Loss	1	1
Electrolyte Imbalance	1	1
Vascular Dissection	1	1
Pulmonary Insufficiency	1	1
Sepsis	1	1
Erythema	1	1
Pleural Effusion	1	1
Failure of Implant	1	1
Dyspnea	1	1
Skin Infection	1	1
Peeling	1	1
Pneumonia	1	1
Tissue Damage	1	1
Unspecified Respiratory Problem	1	1
Superficial (First Degree) Burn	1	1
Loss of consciousness	1	1
Ascites	1	1
Low Blood Pressure/ Hypotension	1	1
Decreased Respiratory Rate	1	1

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