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

Model Number A-EP-028

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

On or about june 4, 2018, epimed received an mdr report that had been completed by (b)(6) hospital (mdr (b)(4)).This mdr report was provided to epimed by the (b)(6).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 Description

Catheter dislodge between the catheter and blue connector.

• Brand Name: 20G SPIROL
• Type of Device: CATHETER
• 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: kris knapp ; 141 sal landrio drive; johnstown, NY 12095
• MDR Report Key: 7639352
• MDR Text Key: 112738395
• Report Number: 1316297-2018-00003
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial

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?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: A-EP-028
• Device Catalogue Number: 194-2036
• Device Lot Number: 16368558
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 11 YR