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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported they were checking the picc dressing and noticed, right below the purple butterfly, the catheter narrows, as if it has been stretched.The dressing remains occlusive, the catheter is secure and doesn't move, and there is no leaking of any fluid.Additional information received stated the catheter slipped out of the purple butterfly hub.There was no medical intervention other than the picc was removed.Picc replacement was attempted but was unsuccessful.
Additional Manufacturer Narrative
The device history record (dhr) review shows that the lot was manufactured according to standards and that there were no discrepancies that could be related to the reported event.Based on review, it is concluded that the lot was released according to product requirements.Additionally, the lot number was reviewed for non-conformances (ncrs) associated and it is determined that there are no ncrs related to this lot number.One photo and fourteen samples were received from the customer for evaluation.It was observed that three samples showed signs of use and the other eleven samples were new and unused.Visual inspection revealed that 2 of the used samples had the butterfly detached from the catheter.Only the three used samples showed the reported condition.This complaint has been confirmed as manufacturing related issue.The root cause, contributing factors, and corresponding actions will be defined in a corrective and preventative action (capa).At this moment, the capa is currently opened.An awareness was performed using the training system for the manufacturing personnel.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 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; edificio b20 calle #2 zona fra; alajuela ; CS
• 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: 13937834
• Report Number: 3009211636-2022-00781
• Device Sequence Number: 14650630
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: 10884527004645
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 1928200149
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown