FDA.reportPublic FDA data

MAUDE MDR 9591749

MDR report key
9591749
Report number
9612030-2020-02393
Event key
0
Event type
3
Date of event
2020-01-07
Date received
2020-01-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JILL SARAIVA
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1N-C CONN TUBE 6MM X3.1MTUBING, NONINVASIVECOVIDIENGAZ888830161488883016141927701964* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-150

Event Narratives#

N

Patient 1

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

D

Patient 1

THE CUSTOMER REPORTED THE CONNECTOR IS NOT ATTACHED TO THE TUBING. ADDITIONAL INFORMATION RECEIVED ON 09-JAN-2020 STATING THAT THERE WERE NO OTHER PHYSICAL ISSUE TO THE TUBING OR THE PACKAGING NOTED. ADDITIONAL INFORMATION RECEIVED ON 13-JAN-2020 STATED THAT BOTH CONNECTORS WERE PRESENT WHICH ONE DETACHED. THE ISSUE WAS FOUND WHEN SETTING UP FOR THE CASE AND NOT IN THE MIDDLE OF THE CASE.