MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. 15G R.K. EPIDURAL NEEDLE

Model Number A-NE-001

Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975); Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

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).

• Brand Name: 15G R.K. EPIDURAL NEEDLE
• Type of Device: 15G R.K. EPIDURAL NEEDLE
• Manufacturer (Section D): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: nathanael wrabel ; 141 sal landrio drive; johnstown, NY 12095 ; 5187250209
• MDR Report Key: 5890246
• MDR Text Key: 52738903
• Report Number: 1316297-2016-00014
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: A-NE-001
• Device Catalogue Number: 100-1415
• Device Lot Number: 12157445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: 1316297-042016-001-R
• Patient Sequence Number: 1