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

Model Number	43303
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results concludes the product met specification requirements.In addition, all dhrs are reviewed prior to product release to confirm all requirements were met.The device was manufactured on february 22, 2019.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate the sample as part of a comprehensive failure investigation.No probable cause was found since no sample, pictures, or videos were received for testing, and therefore the reported issue could not be confirmed.If the sample is returned in the future, the investigation will be updated accordingly.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.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that upon first assessment, blood was found backing up into the argyle single-lumen peripheral inserted central catheter (picc) line.The picc line felt wet and the linen under the infant was wet.The treatment was paused and they disconnected the iv fluids and flushed the line with normal saline.Fluid squirted out of the side of the picc line.After consulting with the health care providers, the picc line was pulled and a new peripheral intravenous line was inserted.There was no patient harm.

• Brand Name: 1.9F ARGYLE SINGLE LUMEN PICC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 12440943
• Report Number: 3009211636-2021-00763
• Device Sequence Number: 20018277
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: 10884527004645
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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
• Operator of Device: No Information
• Device Model Number: 43303
• Device Catalogue Number: 43303
• Device Lot Number: 1905000059
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1
• Patient Age: 9 DA