MAUDE MDR 2068117

MDR report key: 2068117
Report number: 2250033-2011-00007
Event key: 0
Event type: 3
Date of event: 2011-03-13
Date received: 2011-03-31
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 100
Health professional: 3
Initial report to FDA: 3
Event location: 0

Manufacturer Contact#

Contact: LAWRENCE PICCIANO
Address: 20 CORPORATE PLACE SOUTH PISCATAWAY NJ 08854 US
Phone: 732-732-7325
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	TENDERFOOT 50PK DEVICES		INTERNATIONAL TECHNIDYNE CORPORATION	JCA	TF501	TF501	BN036				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2011-03-31	0

Event Narratives#

D

Patient 1

HEALTHCARE PROFESSIONAL REPORTS USER INJURY USING TENDERFOOT 50PK DEVICE. CUSTOMER REPORTED THAT A NURSE WAS USING THE DEVICE TO INCISE A PT. SHE PUT THE DEVICE DOWN ON THE COUNTER EXPECTING THE BLADE TO HAVE RETRACTED. CLEANING UP AFTERWARDS, SHE PICKED UP THE DEVICE AND CUT HER RIGHT THUMB. THE CUT WAS TREATED USING STANDARD NEEDLESTICK PROTOCOL FOR THE SITE. THE CUT WAS WASHED OUT AND WIPED WITH ALCOHOL. NO ADVERSE EVENT (S) REPORTED.

N

Patient 1

(B)(4). METHOD: NO PRODUCT RETURNED. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN. BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED. NO OTHER COMPLAINTS WERE RECEIVED FOR THIS LOT. A SEARCH OF COMPLAINTS FOR THE PAST 2 YEARS INDICATES NO OTHER CASES OF FAILURE TO RETRACT. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
20711234301163	Tenderfoot Newborn Heel Stick Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22
20711234301187	Tenderfoot Newborn Heel Stick Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22
20711234301194	Tenderfoot Newborn Heel Stick Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22
20711234302139	Tenderfoot Preemie Heel Stick Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22
20711234302153	Tenderfoot Preemie Heel Stick Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22
20711234302160	Tenderfoot Preemie Heel Stick Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22
20711234303082	Tenderfoot Toddler Heel Stick Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22
20711234304157	Surgicutt Bleeding Time Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22
20711234312022	Tenderfoot Micro-Preemie Heel Stick Device	ACCRIVA DIAGNOSTICS HOLDINGS, INC.	JCA	2016-09-22

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K911745	JCA	SIMPLATE PEDIATRIC	Organon Teknika Corp.	1991-08-09
510(k)	K911996	JCA	SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION	International Technidyne Corp.	1991-07-17
510(k)	K871318	JCA	Q.I.C. BLEEDING TIME DEVICE	Helena Laboratories	1987-06-10
510(k)	K850542	JCA	SURGICUTT - BLEEDING TIME DEVICE	International Technidyne Corp.	1985-03-01
510(k)	K830645	JCA	BLEEDING TIME DEVICE DISPOSABLE	American Dade	1983-03-17

MAUDE MDR 2068117

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

N

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#