MAUDE Adverse Event Report: CARDINAL HEALTH 1.9F ARGYLE SINGLE LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	43303
Medical Device Problem Codes	Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluated by mfr: device evaluation comment - the customer stated that the device will not be returned for evaluation but did not provide rationale.
Event or Problem Description
Customer reports a failure of the picc catheter.Per additional information received on 09/19/22, a breakage and leaking occurred just below the butterfly where the catheter is joined.Chlorohexadine was used to clean the area prior to insertion, it was then secured with secureport iv adhesive & sorbavion dressing.The product was inserted on (b)(6) 2022 on the right upper extremity basilic and removed on (b)(6) 2022.The device was replaced with another 1.9fr picc line.The patient is doing well.
Additional Manufacturer Narrative
The reported lot number was invalid, therefore a manufacturing device history review (dhr) or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed to meet regulatory requirements prior to product release.The actual sample involved in the reported incident was not returned for evaluation.No additional information, photographs or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation and confirm the reported condition.Based on current manufacturing process, no manufacturing or design issues were identified.As such, the root cause could not be determined based on the available information.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 1.9F ARGYLE SINGLE LUMEN PICC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15504034
• Report Number: 3009211636-2022-00796
• Device Sequence Number: 5224502
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: 10884527004645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 43303
• Device Catalogue Number: 43303
• Device Lot Number: 11343966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown