MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET FULL TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	9173108
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
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 reby2299 showed no other similar product complaint(s) from this lot number.Mw5075878.
Event or Problem Description
It was reported that the picc line was placed in 2018.It was stated that a metallic structure which projects over the right proximal femur was identified during a kub scan.Using ultrasound, the linear hypoechoic structure was confirmed in the anterior musculature of the proximal right thigh, assumed to represent a foreign body 1.3cm long and 5-9mm deep into the skin.Doppler confirmed the foreign body to be extravascular.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET FULL TRAY
• 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: 7478339
• Report Number: 3006260740-2018-00873
• Device Sequence Number: 16472494
• Product Code: LJS
• UDI-Device Identifier: 00801741028564
• UDI-Public: (01)00801741028564
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2018
• Report Date (Section F): 03/13/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9173108
• Device Catalogue Number: 9173108
• Device Lot Number: REBY2299
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2018
• 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: Required Intervention
• Date Report Sent to FDA: 03/13/2018