FDA.reportPublic FDA data

MAUDE MDR 7238311

MDR report key
7238311
Report number
1625685-2018-00001
Event key
0
Event type
3
Date of event
2018-01-09
Date received
2018-02-02
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
BDX ANNA WEHRHEIM
Address
75 N. FAIRVIEW DRIVE VERNON HILLS IL 60061 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULTNEEDLE, SPINAL, SHORT TERMCAREFUSION, INCMIA4301CSP0001160994Y *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-0201. O

Event Narratives#

N

Patient 1

(B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

D

Patient 1

IT WAS REPORTED VIA EMAIL: DURING A LP/CHEMO INJ, THE SPINAL NEEDLE LEAKED CAUSING THE CHEMO TO SPILL OUTSIDE THE NEEDLE, LEAVING THE PATIENT WITH ONLY A SMALL UNKNOWN AMOUNT ACTUALLY BEING INJECTED TO HER SPINAL CANAL. THIS HAS COMPROMISED THE PATIENT'S TREATMENT PLAN. THIS WAS THE FIRST INJECTION OF SEVERAL OVER A PERIOD OF 2 MONTHS. WAS THERE ANY PATIENT HARM OR MEDICAL INTERVENTION REQUIRED? AGAIN, THE PATIENT'S TREATMENT PLAN FOR HER CANCER WAS COMPROMISED. DID THE PATIENT RECEIVE ANOTHER INJECTION AT THAT TIME TO RECEIVE THE CORRECT AMOUNT OF CHEMO? WITHOUT KNOWING THE ACTUAL AMOUNT OF CHEMO THAT WAS INJECTED, WE WERE UNABLE TO REPEAT. WHERE SPECIFICALLY DID THE LEAK OCCUR? AT A CONNECTION SITE? WHICH ONE? THE LEAK OCCURRED AT THE SQUARE HOUSING PART OF THE NEEDLE. IF EFFORT TO STOP THE LEAK, TUBING WAS REPLACED, HUB TIGHTENED, BUT THE LEAK CONTINUED.

N

Patient 1

(B)(4). FOLLOW UP EMDR FOR DEVICE EVALUATION. A SAMPLE TRAY WAS RETURNED FOR SAMPLE EVALUATION HOWEVER THE LEAKING EXTENSION SET WAS NOT INCLUDED IN THE TRAY FOR EVALUATION. CONSEQUENTLY, THE INVESTIGATION WAS NOT ABLE TO EVALUATE THE ACTUAL COMPLAINT SAMPLE. THERE WERE TWO ADDITIONAL, UNOPENED TRAYS THAT INCLUDED EXTENSION SETS THAT WERE TESTED AGAINST OUR QUALITY STANDARD. BOTH EXTENSION SETS PASSED THE QUALITY INSPECTION. THEREFORE, THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED THROUGH THE SAMPLE EVALUATION. A DHR REVIEW FOR LOT 0001160994 DID NOT IDENTIFY ANY MANUFACTURING DEFECTS OR ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THE COMPLAINT SAMPLE EVALUATIONS AND THE DHR REVIEW, NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. CONSEQUENTLY, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A PROBABLE ROOT CAUSE FOR THIS COMPLAINT. SINCE NO PROBABLE ROOT CAUSE WAS IDENTIFIED FOR THE REPORTED FAILURE MODE, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY ANY CORRECTIVE OR PREVENTIVE ACTIONS FOR THIS COMPLAINT. THE COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED AND TRENDED FOR FUTURE OCCURRENCES.