MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 3F S/L PICC WITH SAFETY EXCALIBUR INTRODUCER PUNCTUR-GUARD; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	4133115
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that upon deploying the catheter to be used in the patient, the picc was found to be perforated at the junction between the bevel and the catheter.The catheter was discarded and a new device was used to complete the procedure.The device was not used in/on the patient.

• Brand Name: PER-Q-CATH PLUS 3F S/L PICC WITH SAFETY EXCALIBUR INTRODUCER PUNCTUR-GUARD
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7404034
• Report Number: 3006260740-2018-00644
• Device Sequence Number: 1083793
• Product Code: LJS
• UDI-Device Identifier: 00801741074851
• UDI-Public: (01)00801741074851
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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 Model Number: 4133115
• Device Catalogue Number: 4133115
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1