FDA.reportPublic FDA data

MAUDE MDR 6196046

MDR report key
6196046
Report number
2523676-2016-00907
Event key
0
Event type
3
Date received
2016-12-21
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
MS. BRIDSEIDA MELENDEZ
Address
901 MARCON BLVD ALLENTOWN PA 18109 US
Phone
610-610-6102
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DESIGN OPTIONS?SPINAL ANESTHESIA KITB. BRAUN MEDICAL INC.OFU5606030061495420R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-12-2101. R

Event Narratives#

N

Patient 1

(B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

D

Patient 1

AS REPORTED BY USER FACILITY: APPROXIMATELY 1 INCH OF SPINAL NEEDLE BROKE OFF IN THE PATIENT WHICH REQUIRED THE PATIENT TO RETURN TO THE OPERATING ROOM FOR SURGICAL REMOVAL OF NEEDLE.

N

Patient 1

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.