MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXI; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	1173108D
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/22/2016
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, as the device is being retained by the reporting facility.A lot history review (lhr) of reap0705 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 facility contact reported that a (b)(6) old patient had a picc line insertion done under sedation after being admitted for co abdominal pain, diarrhea, and intolerance of gastrostomy tubes.Nurses reported that they felt resistance and had difficulty removing the internal wire after the picc line was placed.They stated that the distal tip sheared off the internal wire.A post procedure x-ray showed an artifact at the level of the right subclavian vein.X-ray was repeated after picc line was pulled back, and the artifact that was previously noted remained in place.

• Brand Name: POWERPICC SV CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET MAXI
• 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: 5660986
• Report Number: 3006260740-2016-00226
• Device Sequence Number: 10810336
• Product Code: LJS
• UDI-Device Identifier: 00801741087103
• UDI-Public: (01)00801741087103(17)170628(10)REAP0705
• 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): 05/04/2016

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: 06/28/2017
• Device Catalogue Number: 1173108D
• Device Lot Number: REAP0705
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR