MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC 20G SPIROL; CATHETER

Model Number	A-EP-028
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On or about june 4, 2018, epimed received an mdr report that had been completed by (b)(6)hospital ((b)(4)).This mdr report was provided to epimed by the department of health & human service.The mdr report was filed in regard to an epimed 20g spirol catheter that had become dislodged from an epimed stingray catheter connector.No additional information was provided to epimed regarding the reported complaint.On june 18, 2018, the reporting account was emailed in an attempt to gather additional information regarding the reported complaint.The account was unable to provide additional information outside of what was already provided in the mdr that had been previously submitted by the account.The product was not returned to epimed for investigation.The batch history records were reviewed; revealing no abnormalities within the product lot related to the product complaint.
Event or Problem Description
Catheter became disconnected at the blue connector site.

• Brand Name: 20G SPIROL
• Common Device Name: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC; 141 sal landrio drive; johnstown NY 12095
• MDR Report Key: 7639364
• Report Number: 1316297-2018-00006
• Device Sequence Number: 13809132
• Product Code: BSO
• UDI-Device Identifier: 00818788021649
• UDI-Public: 00818788021649
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K981329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/30/2023
• Device Model Number: A-EP-028
• Device Catalogue Number: 194-2036
• Device Lot Number: 16368558
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1