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

Model Number	1194108
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/10/2017
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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) of rebs0423 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported that the wire on sherlock 3cg is frayed.No other information was provided.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Once the sample was returned the evaluation does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.Therefore this event is deemed not reportable per 21 cfr part 803.19.
Event or Problem Description
Facility reported that the wire on sherlock 3cg is frayed.No other information was provided.

• Brand Name: POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS)
• 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: 7023090
• Report Number: 3006260740-2017-02018
• Device Sequence Number: 1331976
• Product Code: LJS
• UDI-Device Identifier: 00801741034503
• UDI-Public: (01)00801741034503
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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 Model Number: 1194108
• Device Catalogue Number: 1194108
• Device Lot Number: REBS0423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1