TPLC - Total Product Life Cycle

• 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

MDR Year	MDR Reports	MDR Events
2018	51	51
2019	57	57
2020	68	68
2021	143	143
2022	62	62
2023	82	82

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	66	66
Material Separation	57	57
Adverse Event Without Identified Device or Use Problem	47	47
Fluid/Blood Leak	38	38
Fracture	35	35
Leak/Splash	34	34
Detachment of Device or Device Component	33	33
Sharp Edges	26	26
Material Puncture/Hole	18	18
Disconnection	14	14
Complete Blockage	12	12
Unsealed Device Packaging	11	11
Tear, Rip or Hole in Device Packaging	10	10
Obstruction of Flow	8	8
Material Twisted/Bent	8	8
Material Split, Cut or Torn	6	6
Device Dislodged or Dislocated	5	5
Physical Resistance/Sticking	4	4
Defective Device	4	4
Defective Component	4	4
Suction Problem	3	3
Device Markings/Labelling Problem	3	3
Separation Failure	3	3
Crack	3	3
Product Quality Problem	3	3
Difficult to Remove	3	3
Occlusion Within Device	2	2
Difficult to Insert	2	2
Decrease in Suction	2	2
Contamination	2	2
Restricted Flow rate	2	2
Patient-Device Incompatibility	2	2
Expiration Date Error	2	2
Component Missing	2	2
Use of Device Problem	2	2
Suction Failure	2	2
Device Contamination with Chemical or Other Material	2	2
Gas/Air Leak	2	2
Migration	2	2
Component Misassembled	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Device Handling Problem	1	1
Patient Device Interaction Problem	1	1
Mechanical Jam	1	1
No Flow	1	1
Improper Flow or Infusion	1	1
Infusion or Flow Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Device Fell	1	1
Improper or Incorrect Procedure or Method	1	1
Stretched	1	1
Malposition of Device	1	1
Device Sensing Problem	1	1
Inaccurate Flow Rate	1	1
Entrapment of Device	1	1
Loose or Intermittent Connection	1	1
Migration or Expulsion of Device	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	235	235
No Consequences Or Impact To Patient	122	123
Insufficient Information	26	26
No Known Impact Or Consequence To Patient	19	19
Pneumothorax	19	19
Unspecified Infection	14	14
Pain	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
No Code Available	10	10
Foreign Body In Patient	9	9
No Information	7	7
Cellulitis	7	7
Peritonitis	5	5
Discomfort	3	3
Radiation Exposure, Unintended	3	3
No Patient Involvement	3	3
Skin Inflammation	3	3
Bacterial Infection	3	3
Dyspnea	3	3
Pleural Empyema	3	3
Death	2	2
Obstruction/Occlusion	2	2
Pressure Sores	2	2
Inflammation	2	2
Irritation	2	2
Adhesion(s)	1	1
Loss of consciousness	1	1
Decreased Respiratory Rate	1	1
Ascites	1	1
Blood Loss	1	1
Superficial (First Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1
Exposure to Body Fluids	1	1
Pulmonary Emphysema	1	1
Erythema	1	1
Hematoma	1	1
Low Blood Pressure/ Hypotension	1	1
Failure of Implant	1	1
Peeling	1	1
Pleural Effusion	1	1
Pneumonia	1	1
Pulmonary Insufficiency	1	1
Tissue Damage	1	1
Electrolyte Imbalance	1	1
Unspecified Respiratory Problem	1	1
Skin Infection	1	1
Skin Inflammation/ Irritation	1	1

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