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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pleural Effusion (2010); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
We have had some issues with insertion the device has infiltrated after a short time.Additional information received on 8/27/21 as a result the patient experienced a pleural effusion.The patient is stable.
Additional Manufacturer Narrative
Updated the following sections based on additional information received from the customer on 8/31/21: b3 / b4 / b5 / b6: describe event or problem.H6: evaluation codes health effect - clinical code.H6: health effect ¿ impact code.H6: type of investigation.
Event or Problem Description
Additional information was received on 8/31/21 picc#2: inserted on (b)(6) 2021 at 5 pm.First attempt on that extremity, no difficulty in inserting the line.Appeared to be in svc on xray.Line infiltrated at midnight within 7 hours.Repeat xray showed the picc to be in similar position, moderate pleural effusion.Infant with respiratory compromise and neck edema.Had to be intubated.Line removed.

• 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
• MDR Report Key: 12380791
• Report Number: 3009211636-2021-00760
• Device Sequence Number: 3938345
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: 10884527004645
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 43303
• Device Catalogue Number: 43303
• Device Lot Number: 1913500227
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 09/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other