MAUDE Adverse Event Report: ACCESS VASCULAR, INC. HYDROPICC; PERIPHERALLY INSERTED CENTRAL CATHETER

Model Number	PICC-142
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2020, a follow up phone conversation with the clinician revealed that, the device was not sutured, but secured by a grip-lok device.It was also noted that a fracture was observed in proximity to the suture wing-to-catheter joint.The device was explanted from the patient, and subsequently replaced with another hydropicc without incident on the same date.It was further reported that the patient had completed all therapy on (b)(6) 2020, and the hydropicc was removed without incident.The clinician stated that there were no complications associated with this event.
Event or Problem Description
It was reported that the hydropicc was placed on (b)(6) 2020 without issue.Then, on (b)(6) 2020, the clinician was contacted to consult on an alleged leaking catheter.On (b)(6) 2020, the clinician communicated, by email, that ".My upstanding[sic] is pt accidentally pulled on the line it was found out a few 3cm secured only by tegaderm by the bedside nurse and we were consulted for leaking line.My nurse found the proximal end dried, kinder[sic] and cracked.""upon sterile saline installation.".

• Brand Name: HYDROPICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ACCESS VASCULAR, INC.; 175 middlesex turnpike; suite 1a; bedford, ma
• MDR Report Key: 10140052
• Report Number: 3015060232-2020-00001
• Device Sequence Number: 2115603
• Product Code: LJS
• UDI-Device Identifier: 00862559000418
• UDI-Public: (01)00862559000418(17)200522(10)03022003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: PICC-142
• Device Catalogue Number: PICC-142
• Device Lot Number: 03022003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 06/10/2020
• 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: Other