INNER CANNULA HCSTIC6A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for INNER CANNULA HCSTIC6A manufactured by Medplast / Viant Medical, Inc..

Event Text Entries

[174180608] We received 4 boxes of 10 each phoneris inner cannulae, ref (b)(4) from our son's respiratory equipment supplier, (b)(4), 17 of the 40 cannulae were misboxed with a larger size cannula put into a sealed and marked smaller container, from lot 35385029. Fortunately we caught the misboxed product before trying to insert it into our son's shiley 6dfen tracheostomy tube and had back-up correct product on hand to use. We have 2 sons on ventilators for the past 9 years and are very familiar with handling any unforeseen problems, but worry about families / caregivers without our experience with traches spending too much time trying to insert the misboxed products and endangering their loved ones from being off the ventilator assist too long. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5092058
MDR Report Key	9558973
Date Received	2020-01-06
Date of Report	2020-01-03
Date of Event	2020-01-02
Date Added to Maude	2020-01-07
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	PATIENT FAMILY MEMBER OR FRIEND
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	3
Previous Use Code	3
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Model Number	HCSTIC6A
Lot Number	35385029
Operator	LAY USER/PATIENT
Device Availability	Y
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 2

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	2
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 3

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	3
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 4

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	4
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 5

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	5
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 6

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	6
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 7

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	7
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 8

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	8
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 9

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	9
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 10

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	10
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 11

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	11
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 12

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	12
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 13

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	13
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 14

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	14
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Device Sequence Number: 15

Brand Name	INNER CANNULA
Generic Name	TRACHEOSTOMY TUBE WITH /WITHOUT CONNECTOR
Product Code	BTO
Date Received	2020-01-06
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	15
Device Event Key	0
Manufacturer	MEDPLAST / VIANT MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-06