MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-08-19 for 15G R.K. EPIDURAL NEEDLE A-NE-001 100-1415 manufactured by Epimed International Inc..
[52740002]
In reference to the needle(s) in question, (b)(4) (receiving inspection report - r. K. Epidural needles) was reviewed and it was discovered that (b)(4) needles were 100% skive tested by epimed's quality control department prior to being printed. During the 100% skive testing, epimed identified (b)(4) needles out of the (b)(4) needles that failed skive testing. At the time of discovery, the needle supplier ((b)(4)) was immediately notified of epimed's findings and asked to investigate the root cause. The remaining (b)(4) needles in the lot which passed epimed's 100% skive inspection; were further processed, i. E. , printed, packaged, and sterilized. Once sterilized, epimed's sales representative, delivered (b)(4) needles to the account in question. On april 8, 2016 the account reported that (b)(4) of these 100% inspected 15 rk needles caused (b)(4) catheters to skive/shear. Upon completion of each procedure, all catheter coating was accounted for and to date, no adverse events have been reported. As mentioned in the original epimed complaint (b)(4), all five of the returned 15g rk needles caused skiving when re-skive tested at epimed. Epimed opened capa (b)(4) to further investigate epimed's skive test method and to also implement additional measures of safety to identify all needles that have been improperly processed. In addition, epimed initiated a recall of the 15g rk needles (1316297-042016-001-r), to which, the recall was successful and has since been closed. Epimed is retrospectively completing this mdr as part of the remedial action to correct the findings in observation 1b-c. In addition, in light of the recent fda inspection epimed has retrospectively opened the following complaints; (b)(4) to individually evaluate each rk needle. This mdr report is filed for epimed (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[52740003]
On april 8, 2016, (b)(6), reported that (b)(6) had additional problems with the replacement brevi-stf catheters and rk needles. The catheters skived while using them with the 100% inspected needles, which were sent as replacements during epimed complaint investigation (b)(4). This is the third complaint from this account involving similar circumstances. The first complaint number ((b)(4)) was investigated in march and has since been closed. Update: the abovementioned incident was initially investigated in (b)(4). However, in light of a recent fda inspection, which occurred between may 26, 2016, through july 12, 2016, it was discovered by fda investigator, (b)(6), within observation #1b-c of the associated 483 form that complaint (b)(4) had multiple reported incidents filed within one complaint and due to this finding it is possible that additional mdr's may need to be filed. Therefore, epimed has retrospectively opened complaints (b)(4) to separately document each rk needle that was returned to epimed on april 12, 2016. The original complaint (b)(4), will remain an active complaint number, due to an mdr (1316297-2016-00003) being associated to the original complaint number and also due to the fact that the returned catheters were examined within complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316297-2016-00016 |
| MDR Report Key | 5890269 |
| Report Source | USER FACILITY |
| Date Received | 2016-08-19 |
| Date of Report | 2016-08-03 |
| Date of Event | 2016-04-08 |
| Date Mfgr Received | 2016-04-12 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2016-08-19 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NATHANAEL WRABEL |
| Manufacturer Street | 141 SAL LANDRIO DRIVE |
| Manufacturer City | JOHNSTOWN NY 12095 |
| Manufacturer Country | US |
| Manufacturer Postal | 12095 |
| Manufacturer Phone | 5187250209 |
| Manufacturer G1 | EPIMED INTERNATIONAL INC. |
| Manufacturer Street | 141 SAL LANDRIO DRIVE |
| Manufacturer City | JOHNSTOWN NY 12095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12095 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1316297-042016-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 15G R.K. EPIDURAL NEEDLE |
| Generic Name | 15G R.K. EPIDURAL NEEDLE |
| Product Code | MIA |
| Date Received | 2016-08-19 |
| Returned To Mfg | 2016-04-12 |
| Model Number | A-NE-001 |
| Catalog Number | 100-1415 |
| Lot Number | 12157445 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPIMED INTERNATIONAL INC. |
| Manufacturer Address | 141 SAL LANDRIO DRIVE JOHNSTOWN NY 12095 US 12095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-19 |