MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH 4F DUAL-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WITH; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rebw0616 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc ruptured 2 hours after the implant procedure.No other information was provided.(b)(6) does not provide any additional information.

• Brand Name: PER-Q-CATH 4F DUAL-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WITH
• 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: 10100688
• Report Number: 3006260740-2020-01871
• Device Sequence Number: 2625302
• Product Code: LJS
• UDI-Device Identifier: 00801741074967
• UDI-Public: (01)00801741074967
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2020

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 4234105
• Device Lot Number: REBW0616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1