MTP1820C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-10-23 for MTP1820C manufactured by Mick Radio-nuclear Instruments, Inc..

Event Text Entries

[5037145] During prostate seed implants at (b)(6) it was reported that during two separate implants, a disposable needle supplied by mick radio-nuclear instruments had been kinked after implanting and a radioactive seed had been struck inside each of the kinked needles. This had occurred in two separate incidents, of which the one in (b)(6) had not been separately reported - they both were reported to mick radio-nuclear instruments after the second incident. According to interviews with operating room staff, the needle had been straight upon opening the package and after implanting, it had gotten kinked. This had been reported to (b)(4), but not fda due to the fact that the pt was not at risk. The needle with the kink was removed with the seed still stuck inside and a different needle was used to complete the implant. The needle fragments remain in quarantine and are due to be returned in the next six months after the seeds degrade. The needle consists of a hollow cannula with a removable sharp stylet that enables the needle to be implanted and then the stylet is removed, leaving a hollow tube with which to implant the radioactive seeds. It is important to note that the inside diameter of the cannula is 0. 042" and the diameter of the stylet is 0. 039". The diameter of the seeds are approximately 0. 030" to 0. 032". Once the needle is implanted, if it is kinked, the stylet will not remove (there is about 0. 003" clearance). Instead the stylet would have gotten stuck inside the cannula instead of the seed. What is clear is that if the stylet can be removed, there is enough clearance in the needle for the seed to be implanted successfully. However, the evidence indicates that after the stylet had been removed (in order to implant the needle) and the needle had been impacted after being implanted. It was determined that the mick product (the needle) did not malfunction as it was implanted as per standard procedure, but after implanting, the adverse incident occurred. I reported this to (b)(4) and their response back to me was that they accepted my investigation and the issue was closed. Due to the favorable response from (b)(4) and the fact that the incident occurred in the (b)(6) and not the us, and especially since the patient was not put at risk, mick radio-nuclear instruments had decided not to report the incident to fda. We feel that our product in question performed up to specification and the incident was not due to the integrity of the mick needle. However, upon review, this report is being submitted retroactively to fda for information purposes.
Patient Sequence No: 1, Text Type: D, B5


[12449732] Please reference mfr report number 2431392-2014-00001.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2431392-2014-00003
MDR Report Key4203254
Report Source08
Date Received2014-10-23
Date of Report2014-10-23
Date of Event2013-06-10
Date Mfgr Received2013-07-26
Date Added to Maude2014-11-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer Street521 HOMESTEAD AVE.
Manufacturer CityMOUNT VERNON NY 10550
Manufacturer CountryUS
Manufacturer Postal10550
Manufacturer Phone9146673999
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMTP1820C
Generic NameMICK TP NEEDLE - 18 GAUGE, 892.5650
Product CodeIWJ
Date Received2014-10-23
Model NumberMTP1820C
Catalog NumberMTP1820C
Lot Number120626-01
Device Expiration Date2016-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICK RADIO-NUCLEAR INSTRUMENTS, INC.
Manufacturer AddressMOUNT VERNON NY 10550 US 10550


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-10-23

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