MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 6.6F JET CT PORT LP ATT POLY; JET PORT

Model Number JSACTI6604S

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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

During implantation of the port it was noted the introducer was too large.Patient required additional intervention to control the bleeding caused by the introducer size.Patient reported to have lost approximately 500 cc of blood.

Manufacturer Narrative

No device was returned and no photographs were provided.A supplier corrective action request (scar s-21-013) was issued to the contract manufacturer for a similar event.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: 6.6F JET CT PORT LP ATT POLY
• Type of Device: JET PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11483329
• MDR Text Key: 239734123
• Report Number: 2518902-2021-00016
• 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: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: JSACTI6604S
• Device Catalogue Number: JSACTI6604S
• Device Lot Number: MNHR880
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 65