MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-11-17 for MICK FLEXIGUIDE NEEDLE 17 GAUGE X 25 CM 0919 manufactured by Mick Radio-nuclear Instruments, Inc..
[15346781]
Distributor reported on (b)(4) 2014 to (b)(4) instruments inc that the tip of one mick flexiguide needle used in an hdr gyn treatment had broken. When the hosp was contacted, the incident was described as follows: needles were visually checked prior to implant and all were found to be good and not visually defective. Ten needles were implanted through a template into the treatment area without incident. When a length check was conducted on each needle prior to treating pt, it was found that the needle in channel #7 measured long. The measurement wire was removed and there was no visible damage to the sire or fluids present. Channel #7 was not used and the treatment plan was adjusted adequate to cover the target area. After completion, needle #7 was removed and it was observed that the tip of the flexiguide was missing. The physicist reported that there was no mis-administration and the pt was treated safely per the adjusted treatment plan.
Patient Sequence No: 1, Text Type: D, B5
[15669281]
Physicist stated that pathfinder needles (which are strongly recommended in our instructions for use) were not used. This would have provided a pathway into the tissue and relieved the stress on the plastic flexiguide. Please not the obturator is designed and manufactured to not contact the tip in order to decrease the force exerted on the tip of the needle. Possible causes: bone interference (needle hitting bone upon insertion of needle). Physician technique (inserting the flexiguide needle requires the obturator to be inserted completely). If not, a void could be created at the base, weakening the tip of the needle. Use of another mfr's template. Use of undo force in insertion.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431392-2014-00004 |
| MDR Report Key | 4289550 |
| Report Source | 08 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-11-14 |
| Date of Event | 2014-10-28 |
| Date Mfgr Received | 2014-11-04 |
| Device Manufacturer Date | 2011-02-16 |
| Date Added to Maude | 2014-12-05 |
| 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 | MICK FLEXIGUIDE NEEDLE |
| Generic Name | MICK FLEXIGUIDE NEEDLE |
| Product Code | IWJ |
| Date Received | 2014-11-17 |
| Model Number | 17 GAUGE X 25 CM |
| Catalog Number | 0919 |
| Lot Number | 110216-02 |
| Device Expiration Date | 2015-01-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-11-17 |