MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGROSHONG 5F SINGLE-LUMEN SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Codes	Extravasation (1842); Unspecified Infection (1930); Irritation (1941); Thrombosis (2100)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx1156 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that patient allegedly developed extravasation, irritant type, following the fourth and the last cycle of chemotherapy, due to extravasation of docetaxel through an alleged leak of the picc line; the picc was very gently withdrawn and immediately fractured at the kinked catheter site.The short fragment separated from the long picc.The picc was immediately buried in the subcutaneous tissues of the right arm.Entire picc demonstrates integrity up to just beneath the access site where the picc is kinked in the subcutaneous tissues.Most likely, there was a pinch off which resulted in weakness of the catheter and a small tear in the picc resulting in extravasation of infused medications causing arm edema and venous thrombosis.Patient was admitted for five days with complications related to this event - right arm dvt and cellulitis/irritative contact dermatitis (right upper extremity) due to extravasation of chemotherapy (docetaxel).

• Brand Name: POWERGROSHONG 5F SINGLE-LUMEN SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8482468
• Report Number: 3006260740-2019-00770
• Device Sequence Number: 11193478
• Product Code: LJS
• UDI-Device Identifier: 00801741028533
• UDI-Public: (01)00801741028533
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: N/A
• Device Catalogue Number: 7818518
• Device Lot Number: RECX1156
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention