JARET (2 STRAIGHTS) JARET (105-170) *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-24 for JARET (2 STRAIGHTS) JARET (105-170) * manufactured by Jarot Surgical.

Event Text Entries

[101639] An infant was delivered with a tight nuchal cord, which was clamped with hemostats and cut. The cord had been left 6 in. Long. Initial apgar was 3-5. At 3 minutes post delivery, in lifting infant it was noted that there was dark red blood directly under infant on blanket. Size approx. 7 in x 4in. The cord was under infant and no hemostat was attached. A hemostat was found on floor by side of bed. In the ensuing care of infant the specific hemostat became mixed with 3 others and could not be identified as the one bound on the floor. Infant given albumin and blood and discharged home on 10/11 in good condition. The hemostats were 2 curved and 2 straights.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 128502
• MDR Report Key: 128502
• Date Received: 1997-10-24
• Date of Report: 1997-10-20
• Date of Event: 1997-10-09
• Date Facility Aware: 1997-10-10
• Date Reported to FDA: 1997-10-20
• Date Reported to Mfgr: 1997-10-20
• Date Added to Maude: 1997-10-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: JARET (2 STRAIGHTS)
• Generic Name: HEMOSTAT
• Product Code: HRQ
• Date Received: 1997-10-24
• Model Number: JARET (105-170)
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 125709
• Manufacturer: JAROT SURGICAL
• Manufacturer Address: 9 SKYLINE DR HAWTHORNE NY 10532 US

Device Sequence Number: 2

• Brand Name: MUELLER (CURVED)
• Generic Name: HEMOSTAT
• Product Code: HRQ
• Date Received: 1997-10-24
• Model Number: MUELLER (SU2760)
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 125710
• Manufacturer: MUELLER
• Manufacturer Address: 1435 LAKE COOK RD DEERFIELD *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	1997-10-24