15G R.K. EPIDURAL NEEDLE A-NE-001 100-1415

MAUDE Adverse Event Report

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..

Event Text Entries

[52738903] In reference to the needle(s) in question, the ihr-405 (receiving inspection report - (b)(6) epidural needles) was reviewed and it was discovered that 887 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 (spectra medical) 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 (b)(6) 2016 the account reported that (b)(4) of these 100% inspected (b)(4) 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 (b)(4) 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 (b)(4) 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 complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[52738904] On (b)(6) 2016, (b)(6), sales consultant, reported that the surgery center of (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 complaint (b)(4). However, in light of a recent fda inspection, which occurred between (b)(6) 2016, through (b)(6) 2016, it was discovered by fda investigator, (b)(6), within observation #(b)(6) of the associated (b)(6) 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 (b)(6) 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


MAUDE Entry Details

Report Number1316297-2016-00014
MDR Report Key5890246
Report SourceUSER FACILITY
Date Received2016-08-19
Date of Report2016-08-03
Date of Event2016-04-08
Date Mfgr Received2016-04-12
Device Manufacturer Date2016-03-31
Date Added to Maude2016-08-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. NATHANAEL WRABEL
Manufacturer Street141 SAL LANDRIO DRIVE
Manufacturer CityJOHNSTOWN NY 12095
Manufacturer CountryUS
Manufacturer Postal12095
Manufacturer Phone5187250209
Manufacturer G1EPIMED INTERNATIONAL INC.
Manufacturer Street141 SAL LANDRIO DRIVE
Manufacturer CityJOHNSTOWN NY 12095
Manufacturer CountryUS
Manufacturer Postal Code12095
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction Number1316297-042016-001-R
Event Type3
Type of Report3

Device Details

Brand Name15G R.K. EPIDURAL NEEDLE
Generic Name15G R.K. EPIDURAL NEEDLE
Product CodeMIA
Date Received2016-08-19
Returned To Mfg2016-04-12
Model NumberA-NE-001
Catalog Number100-1415
Lot Number12157445
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerEPIMED INTERNATIONAL INC.
Manufacturer Address141 SAL LANDRIO DRIVE JOHNSTOWN NY 12095 US 12095


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-19

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