15G R.K. EPIDURAL NEEDLE (TW) 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 (TW) A-NE-001 100-1415 manufactured by Epimed International Inc..

Event Text Entries

[52622857] On (b)(6) 2016, (b)(4), materials manager for the surgery center of (b)(4), reported that the account had some more problems with three brevi-stf catheters skiving/shearing. At the time this complaint was originally reported, it was the second reported complaint of its kind from this account. The first complaint (b)(4), was investigated earlier in the month and had since been closed. The material manager, (b)(4) reported that two incidents occurred, one on (b)(6) 2016, with dr. (b)(6) and one on (b)(6) 2016, with dr. (b)(6). On (b)(6) 2016, the account returned three brevi-stf catheters and two 15g rk needles to epimed for an investigation. Once the products were returned they were inadvertently investigated as one complaint (b)(4). However, in light of a recent fda inspection that occurred from may 26, 2016, through july 12, 2016, it was discovered by fda investigator, (b)(4), that complaint (b)(4) had multiple reported incidents filed within one complaint. Therefore, epimed has opened two complaints (b)(4) to document the each reported event separately. The original complaint (b)(4), will remain an active complaint number, due to an mdr (1316297-2016-00002) being associated to the original complaint number. The original mdr (1316297-2016-00002), filed within complaint (b)(4) was updated on july 7, 2016, to reflect that the rk needle reported on (b)(6) 2016, to be the most likely root cause of the reported complaint. Per (b)(4)'s investigation, there was no manufacturing fault found related to the brevi-stf catheters returned to (b)(4) on (b)(6) 2016, and all the skive/sheared catheter (fep) coating was accounted for. However, since the closure of the original complaint (b)(4), (b)(4) discovered that their 15g rk needles were not processed properly at the supplier's facility. Therefore, (b)(4) initiated recall 1316297-04/20/16-001-r for the 15g rk needles. The recall number is 1316297-042016-001-r. The recall was opened on april 20, 2016, and was later closed on may 9, 2016. The recall involved three different sterile lot numbers (12157181, 12157325, & 12157445), two of which were lot numbers of 15g rk needles (100-1415, lot # 12157325 & lot# 12157181) that were sent to the account in question. The recall has since been closed and all of the effected 15g rk needles have been returned to (b)(4) and destroyed. Lastly, per (b)(4)'s most recent complaint report (b)(4), epimed has determined that it is necessary to retrospectively file a separate mdr for this complaint/event that occurred on (b)(6) 2016. This determination was due to the fact that it is impossible to determine which needle was used on which date, and the fact that both of the returned needles caused skiving when tested using epimed's sample test catheters.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1316297-2016-00007
MDR Report Key5890182
Report SourceUSER FACILITY
Date Received2016-08-19
Date of Report2016-07-26
Date of Event2016-03-21
Date Mfgr Received2016-03-30
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 Number1316297-04/20/16-001-R
Event Type3
Type of Report3

Device Details

Brand Name15G R.K. EPIDURAL NEEDLE (TW)
Generic Name15G R.K. EPIDURAL NEEDLE (TW)
Product CodeMIA
Date Received2016-08-19
Returned To Mfg2016-03-30
Model NumberA-NE-001
Catalog Number100-1415
Lot Number12157181 OR 12157325
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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