MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Foreign Body In Patient (2687)
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) of recu1914 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a dual lumen powerpicc solo insertion was attempted on (b)(6) 2018, unsuccessful w/ multiple attempts.It was stated that rn was able to cannulate but was not placed in svc- aborted.Then a second clinician attempted with a single lumen, and unsuccessful.The patient came back to the hospital (monday (b)(6) 2018) with complaints of swelling and pain in right arm.Then patient was admitted after assessments and tests it was noted a 2.6 cm segment of wire in right subclavian vein.This report addresses the first catheter.Additional information received stated, "we were unable to advance the catheter past the level of the right subclavian.Resistance to the catheter was noted by both practitioners at the same point (the level of the right subclavian).No attempts were made to advance the catheter or the wire beyond that.Contralateral attempt not possible due to radical mastectomy with lymph node resection.".

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• 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: 8189527
• Report Number: 3006260740-2018-03695
• Device Sequence Number: 16710854
• Product Code: LJS
• UDI-Device Identifier: 00801741124075
• UDI-Public: (01)00801741124075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: CK000525A
• Device Lot Number: RECU1914
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/21/2018
• 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