MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F JET CT PORT LP ATT POLY; INFUSION PORT

Model Number JSACTI8004S

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The incision for implanting the port had been made when it was noted that the introducer size is smaller than the catheter.When the doctor attempted insertion the procedure could not be completed.Two additional kits from the same lot were opened but the same issue was encountered.As a result the procedure to implant the port was cancelled.

Manufacturer Narrative

No device was returned and no photographs were provided.A supplier corrective action request was issued to the contract manufacturer.The contract manufacturer's investigation revealed the root cause of this issue was mislabeling of the devices upon receipt from their supplier, as well as a mixing of components while on the production floor.It was also noted that some partial lots were delivered to the production floor prior to completion of the lot.As a result, packaging and inspection procedures have been revised by the contract manufacturer.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.

• Brand Name: 8F JET CT PORT LP ATT POLY
• Type of Device: INFUSION PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11327737
• MDR Text Key: 232562914
• Report Number: 2518902-2021-00009
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: JSACTI8004S
• Device Catalogue Number: JSACTI8004S
• Device Lot Number: MNZJ160
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 55