MAUDE Adverse Event Report: CENTURION; PUMP REFILL CONVENIENCE KIT

Catalog Number	C9000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 the "gablofen" was "leaking" on the "distal end of the extension line at the hub/connector between the line and the huber needle".The customer reported after the incident occurred the medication leak was "cleaned" off the patient's skin and a new "gablofen" syringe was put into the pump.According to the customer, "a very minimal amount of the original syringe was administered" and "the full dose (from a new syringe) on the second attempt was delivered to the patient's intrathecal pump".The customer reported no serious injury, medical intervention/attention, or follow-up care needed related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2023 the "gablofen" was "leaking" on the "distal end of the extension line at the hub/connector between the line and the huber needle".

• Common Device Name: PUMP REFILL CONVENIENCE KIT
• Manufacturer (Section D): CENTURION; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18830967
• Report Number: 3004519921-2024-00010
• Device Sequence Number: 7878995
• Product Code: LRP
• UDI-Device Identifier: 00858688006827
• UDI-Public: 00858688006827
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: C9000
• Device Lot Number: 2023051790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown