MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SHERLOCK 3CG BARD MYPICC KIT (4F) (SINGLE LUMEN) (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 picc was inserted by picc rn on (b)(6) 2019.Picc was functioning fine for chemotherapy administration until (b)(6) 2019.Patient was to get picc removed (b)(6), but rn in outpatient infusion center was unable to remove picc.Patient was sent to ed to have picc team attempt removal.When the picc rn pulled the picc ever so slightly to remove it, the picc broke off.21 cm of picc was left in patient.Patient was sent to or, vascular surgeon did a cut down to remove picc successfully.Patient was discharged.

• Brand Name: POWERPICC SHERLOCK 3CG BARD MYPICC KIT (4F) (SINGLE LUMEN) (TPS)
• 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: 8722817
• Report Number: 3006260740-2019-01718
• Device Sequence Number: 1756629
• Product Code: LJS
• UDI-Device Identifier: 00801741042966
• UDI-Public: (01)00801741042966
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: CK000170A
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/21/2019
• 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: Required Intervention