MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC SOLO 5F TL; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	CK000637
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2017
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.A lot history review (lhr) of 17pb4834 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per medwatch report, the facility reported: "patient prepped and draped per procedure protocol.Right brachial vein accessed with 21g needle removed over wire.5fr micro-introducer advanced over 0.018 guidewire.Guidewire removed from micro-introducer and micro-introducer dilator capped off with dead end cap.Picc prepped for insertion.Dilator removed from breakaway sheath.Picc inserted without issue.Picc tip placement verified with sherlock and 3cg.Upon trying to remove the breakaway sheath one of the red finger pieces that normally is used to split the sheath and pull it out broke away from the sheath.Sheath portion remained intact and was removed over the external portion of the picc line then split and removed away from the line with the remaining red finger piece.Breakaway sheath visually inspected no pieces missing.Picc line secured and dressed per policy.Pcxr obtained that included the right arm.Picc line appears to be in good position and nothing else noted on x-ray.

• Brand Name: DOT PPICC SOLO 5F TL
• 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: 6872100
• Report Number: 3006260740-2017-01646
• Device Sequence Number: 566760
• Product Code: LJS
• UDI-Device Identifier: 00801741128233
• UDI-Public: (01)00801741128233
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/18/2017
• Report Date (Section F): 08/07/2017

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: 07/31/2018
• Device Model Number: CK000637
• Device Catalogue Number: CK000637
• Device Lot Number: 17PB4834
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 23
• Date Report Sent to FDA: 08/07/2017