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

Model Number	43304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history review (dhr) for the finish good was performed and it revealed no discrepancies that may have contributed to a complaint of this reported condition.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The distributor stated that the device was not available to be returned therefore a sample analysis was not possible and the reported condition could not be confirmed.Based on current manufacturing process no manufacturing or design issues were identified.As such, the root cause could not be determined based on available information.If the sample is returned in the future, this complaint will be re-opened for further investigation.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.
Event or Problem Description
The customer reported that the catheter was reviewed because the healing was observed to be wet, it was withdrawn 12 cm and after 10 cm it presented a break (2 cm introduced into the patient).The ccp had to be changed, which implies in a neonatal patient.Per additional information received on 13apr2022, the break occurred somewhere in the catheter¿s body.At 10 cm from inserting the picc, it presented a perforation, which they realized when curing the patient.The area was cleaned with chlorhexidine without an alcohol base (and in premature babies they use 70% alcohol) and dried prior to insertion.It was not difficult to handle or secure the catheter.The catheter was secured with gauze with fixomull.They used a double lumen with continuous irrigation.They used a syringe of 1 and 3 cc to flush the lines.

• Brand Name: 1.9 FR ARGYLE DUAL 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: 14120787
• Report Number: 3009211636-2022-00785
• Device Sequence Number: 11335637
• Product Code: LJS
• UDI-Device Identifier: 10884527004652
• UDI-Public: 10884527004652
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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
• Report Date (Section B): 04/15/2022

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: 43304
• Device Catalogue Number: 43304
• Device Lot Number: 1833800097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown