MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-04-11 for PROSTATE SEEDING NEEDLE APPLICATOR TECHNIQUE PSS1820AT manufactured by Biocompatibles Inc.
[16437902]
This is a medical device report. On the (b)(6) 2011, a telephone call was received by a (b)(6) customer services rep informing that during a brachytherapy procedure, an entire box of needles would not lock into the mick applicator. The reporter did not provide any further info. Pt info for three pts were provided for traceability purposes, however, no info was provided as to which pt was involved in the procedure when the issue was identified. The outcome of the procedure was not reported and no adverse event or pt injury was reported as a result of this medical device issue. The complaint has been investigated and appropriate capa actions implemented. A root cause analysis identified that the reason for the malfunction was due to a mfg issue relating to a percentage of needles from sterility lot #116261 and 116589. A product recall was initiated (recall number z-0040-2012). The mfg issue has been resolved and product recall z-0040-2012 was confirmed as closed by the fda on the 09/21/2012. This case was reported as part of the recall, however, biocompatibles inc has performed a retrospective review of complaints and it was identified as part of the retrospective review that this case had not been reported as a medical device reported.
Patient Sequence No: 1, Text Type: D, B5
[16669995]
The device malfunction resulted in the device not being used during the procedure, however, the issue was identified once the pt was in the operating room. The device failed prior to use and there was no report of pt harm or injury. The suspect devices that failed to lock were not returned to the mfr because company protocol considers any device that has been moved into the operating room to be considered as a potential bio-hazard. An eval was performed using two in house mick applicators and needles from the same lot. A root cause analysis identified that a retaining screw on mold slide was not fully engaged resulting in an increased hub length of. 002-. 005 longer than typical. A product recall was performed for the affected lots and the mold from applicator needles has been fitted with a locking mechanism to ensure mold slide cannot move if a retaining screw is not fully engaged to avoid future occurrence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1225114-2013-00002 |
| MDR Report Key | 3136424 |
| Report Source | 00,06 |
| Date Received | 2013-04-11 |
| Date of Report | 2013-11-04 |
| Date Mfgr Received | 2011-08-01 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2013-06-17 |
| 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 Contact | WAYNE RICHARDSON, DIR |
| Manufacturer Street | 115 HURLEY ROAD BLDG 3 |
| Manufacturer City | OXFORD CT |
| Manufacturer Country | US |
| Manufacturer Phone | 2032624198 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0040-2012 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTATE SEEDING NEEDLE APPLICATOR TECHNIQUE |
| Generic Name | MANUAL RADIONUCLIDE APPLICATOR SYSTEM |
| Product Code | IWJ |
| Date Received | 2013-04-11 |
| Model Number | PSS1820AT |
| Lot Number | 116261 |
| Device Expiration Date | 2016-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOCOMPATIBLES INC |
| Manufacturer Address | OXFORD CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-11 |