FDA.reportPublic FDA data

MAUDE MDR 9680848

MDR report key
9680848
Report number
2523676-2020-00028
Event key
0
Event type
3
Date received
2020-02-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JONATHAN SEVERINO
Address
901 MARCON BLVD. ALLENTOWN PA 18109 US
Phone
484-484-4847
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PENCAN?SPINAL ANESTHESIA KITB. BRAUN MEDICAL INC.OFU3338513338510061690252R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0701. R

Event Narratives#

N

Patient 1

(B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

D

Patient 1

AS PER MEDWATCH FORM: MW5092165. "PATIENT WAS SCHEDULED FOR SURGERY WITH SPINAL ANESTHESIA. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE NEEDLE WAS MISSING. XRAY VERIFIED THAT ONE THIRD OF THE NEEDLE WAS LODGED IN THE PATIENT'S SUBCUTANEOUS TISSUE. THE NEEDLE WAS IN THE DEEP FASCIA, NOT NEAR THE SPINE AND WAS BENT. AN ADDITIONAL PROCEDURE WAS NEEDED TO REMOVE THE RETAINED NEEDLE TIP. THERE WERE NO LASTING INJURY TO THE PATIENT."