MAUDE Adverse Event Report: FIRST PICC S/L 18GA (4F) 1.35MM X 65CM

Model Number	384157
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is expected to return for evaluation.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Picc implantation was performed for the patient on june 22, and fluid leakage was found on july 31.
Additional Manufacturer Narrative
One catheter was returned for review and leakage was confirmed just below the inverted triangle beneath the securement disc.Careful handling is required during the procedure as not to cause damage to the soft silicone catheter.The ifu warns users: do not use hemostats or clamps on catheter or hub connection.Never use catheter for high-pressure injection.Syringes smaller than 10 ml and mechanical high-pressure injectors can generate pressures capable of rupturing the catheter.Never use force to flush the catheter if resistance is met.Solutions containing high concentrations of alcohol can temporarily weaken the structure of polyurethane material.For polyurethane catheters, minimize exposure to alcohol solutions.Do not expose the catheter to acetone or acetone/alcohol solutions.Do not use if package is opened or damaged.Do not cut stylet.If cut, stylet can potentially damage the catheter and harm the patient.Never use force to advance the catheter.Resistance could indicate a vein obstruction or malposition of the catheter.Never use force to remove the stylet.Resistance can damage the integrity of the catheter and the stylet.Do not hold the catheter with forceps while removing the stylet.Syringes smaller than 10 ml can generate high pressures (greater than 40 psi) capable of rupturing the catheter.Never place tape strips over the catheter tubing.This will compromise the strength and integrity of the tubing.
Event or Problem Description
Picc implantation was performed for the patient on (b)(6), and fluid leakage was found on (b)(6).

• Brand Name: FIRST PICC S/L 18GA (4F) 1.35MM X 65CM
• Common Device Name: FIRST PICC
• MDR Report Key: 12320613
• Report Number: 0001625425-2021-01063
• Device Sequence Number: 4418222
• Product Code: FOZ
• UDI-Device Identifier: 00886333209682
• UDI-Public: 00886333209682
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2023
• Device Model Number: 384157
• Device Catalogue Number: 384157
• Device Lot Number: 11344127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2021
• Supplement Date Received by Manufacturer: 07/31/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other