MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-08-18 for MTP1820C manufactured by Mick Radio-nuclear Instruments, Inc..
[15359495]
During prostate seed implants at (b)(6) hospital in (b)(6), it was reported that during two separate implants, a disposable needle supplied by mick radio-nuclear instrument 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)(6) 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)(6) and their response back to me was that they accepted my investigation and the issue was closed. Due to the favorable response from (b)(6) and the fact that the incident occurred in the (b)(6) and not the u. S, 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
[15671653]
Please reference mfr report number: 2431392-2014-00003.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431392-2014-00001 |
| MDR Report Key | 4085528 |
| Report Source | 01,08 |
| Date Received | 2014-08-18 |
| Date of Report | 2014-08-04 |
| Date of Event | 2013-04-29 |
| Date Mfgr Received | 2013-07-26 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2014-10-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 521 HOMESTEAD AVE. |
| Manufacturer City | MOUNT VERNON NY 10550 |
| Manufacturer Country | US |
| Manufacturer Postal | 10550 |
| Manufacturer Phone | 9146673999 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MTP1820C |
| Generic Name | MICK TP NEEDLE - 18 GAUGE, 892.5650 |
| Product Code | IWJ |
| Date Received | 2014-08-18 |
| Model Number | MTP1820C |
| Lot Number | 103118-05 |
| ID Number | NA |
| Device Expiration Date | 2016-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
| Manufacturer Address | MOUNT VERNON NY 10550 US 10550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-18 |