MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS Medline Industries, Inc.; PICC KIT 4F SL PL MAX BARRIER

Model Number	DYNJ70141MB
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 when 'attempting to place a picc line the nurse met resistance while threading the guidewire'.Per the facility the nurse attempted to thread the guidewire multiple times without success immediately withdrawing the guidewire after needle placement was verified to ensure vessel access.An abdominal/chest ct was performed and confirmed that no foreign body dislodged in the patient.Per the facility, access was placed via the right internal jugular in order to provide the required treatment as the patient was noted to go into an atrial fibrillation with rapid ventricular response.Per the facility the patient has been discharged home.The sample was returned for evaluation, however, a definitive root cause could not be determined.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.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 facility on (b)(6) 2022 when 'attempting to place a picc line the nurse met resistance while threading the guidewire'.

• Brand Name: Medline Industries, Inc.
• Common Device Name: PICC KIT 4F SL PL MAX BARRIER
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico; s. de r.l. de c.v.; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16130514
• Report Number: 3004519921-2023-00001
• Device Sequence Number: 7654943
• Product Code: LRS
• UDI-Device Identifier: 10889942722808
• UDI-Public: 10889942722808
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/10/2023

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: DYNJ70141MB
• Device Catalogue Number: DYNJ70141MB
• Device Lot Number: 2022052590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown