MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 13.5FX20CM SIL DBL LMN W/STYLE; HEMO-CATH ST

Model Number SDL138E

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for additional information.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

At the beginning of december we had a patient on the cvvhd who was lying on his stomach.After turning, without tension on the line, the line was suddenly out.The blue suture wing was still attached to the patient.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.One photograph was provided showing the suture wing attached to the patient's chest and no catheter, confirming the complaint.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.When attaching the suture wing to the hub, the operator must push firmly until the suture wing has entered the slot and is secured after the suture wing is assembled onto the hub, it is rotated several times to ensure free movement and proper positioning on the hub.A review of the engineering verification testing noted that all samples tested exceeded the iso suture wing pull force requirements.Without an evaluation of the device involved in the incident we are unable to determine the cause or factors that may have contributed to this event; however it appears that enough force was applied to the catheter to dislodge it from the suture wing.

• Brand Name: 13.5FX20CM SIL DBL LMN W/STYLE
• Type of Device: HEMO-CATH ST
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 13252718
• MDR Text Key: 289490102
• Report Number: 2518902-2022-00009
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00884908042351
• UDI-Public: 884908042351
• Combination Product (y/n): N
• Reporter Country Code: NP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SDL138E
• Device Catalogue Number: SDL138E
• Device Lot Number: MPGK750
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/13/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 90 KG