MAUDE Adverse Event Report: CENTURION MEDLINE; TRIPLE LUMEN INSERTION BUNDLE

Model Number	ECVC4335
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 when attempting to insert a central line into the "right ij" the introducer was noted to have "a hole".The customer reported a new kit was obtained and the patient required "multiple punctures" in order to use the "right ij".No additional information is available at this time.Sample requested to be returned.It has been determined that the reported event caused or contributed to serious injury therefore, 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 when attempting to insert a central line into the "right ij" the introducer was noted to have "a hole".

• Brand Name: MEDLINE
• Common Device Name: TRIPLE LUMEN INSERTION BUNDLE
• 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: 16448403
• Report Number: 3004519921-2023-00006
• Device Sequence Number: 17610551
• Product Code: OES
• UDI-Device Identifier: 10653160357285
• UDI-Public: 10653160357285
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/27/2023

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 Model Number: ECVC4335
• Device Catalogue Number: ECVC4335
• Device Lot Number: 2022100490
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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