MAUDE Adverse Event Report: FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN

Model Number	384221
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2021
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
¿please be advised that one of our 1.9 french caths was found broken, snapped at the hub, product number ar384221.On (b)(6) 2021 (picc was placed 6/25), dressing intact, entire catheter removed, no harm to patient due to active recovery by nursing.¿.
Event or Problem Description
¿please be advised that one of our 1.9 french caths was found broken, snapped at the hub, product number ar384221.On (b)(6) 2021 (picc was placed (b)(6)), dressing intact, entire catheter removed, no harm to patient due to active recovery by nursing.¿.
Additional Manufacturer Narrative
A review of one catheter found breakage beneath the securement disc, confirming the complaint.Jagged edges were observed at the breakage site indicating the cause of the catheter damage was related to a tensile force being applied to the catheter.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.

• Brand Name: FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
• Common Device Name: FIRST PICC
• MDR Report Key: 12205721
• Report Number: 0001625425-2021-01036
• Device Sequence Number: 17136438
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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 Model Number: 384221
• Device Catalogue Number: 384221
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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