MAUDE Adverse Event Report: INTERRAD MEDICAL SECURACATH; SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE

Model Number	SCR-01
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, (b)(6) medical received a report of a 5f securacath device not snapping together when placed on an arrow 5.5 f midline catheter.(b)(6) medical received the device involved in the event and performed an evaluation.The evaluation included a review of internal documents, physical examination, and testing.There were no concerns identified with the internal document review and the device was able to be placed onto a 5.5f arrow catheter without issue.There were no indications of any manufacturing defects, only minor physical damage noted.Based on the fact that both cover and base of the securacath had signs of minor physical damage that is consistent with pressing the cover and base together when the base towers are misaligned with the cover slots, it had to of occurred at the users facility.This type of matching damage on both base and cover could not happen during the manufacturing, packaging and shipping process as the base and cover do not touch until the user snaps them together.It is only at the user facility that the cover and base come into contact with each other.This was not a malfunction of the securacath device and no injury was reported.This is being reported to provide a response to the user facility report of a securacath device malfunction (medwatch report #(b)(4)).The conclusion of (b)(6) medical's evaluation is that there was not a malfunction of the device but the cause of the issue was the misalignment of the base towers with the cover slots.This misalignment was most likely due to the catheter being offset within the groove of the securacath's base.When the catheter is not properly aligned within the groove of the base, it can be difficult to snap the cover onto the base.This can be avoided by making sure per step 11 of the instructions for use,"align the catheter with the groove in the anchor base" before placing the cover on.
Event or Problem Description
(b)(6) medical clinical educator received a call about a nurse who was placing a 5f securacath device on an arrow 5.5f midline catheter and was unable to snap the securacath base and cover together.She opened a new one that worked without any problems and saved that device that did not snap together.The device was returned to (b)(6) medical and was able to be snapped on to a 5.5f arrow midline catheter without issue.

• Brand Name: SECURACATH
• Common Device Name: SUBCUTANEOUS ENGINEERED STABILIZATION DEVICE
• Manufacturer (Section D): INTERRAD MEDICAL; 181 cheshire lane; suite 100; plymouth MN 55441
• MDR Report Key: 8693483
• Report Number: 3007795799-2019-00002
• Device Sequence Number: 1655551
• Product Code: OKC
• UDI-Device Identifier: 00865382000228
• UDI-Public: (01)00865382000228(17)200831(10)A1827
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: SCR-01
• Device Catalogue Number: 400110
• Device Lot Number: A1827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 82