MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV 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 Code	No Code Available (3191)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recr1551 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the purple hub of the picc was noted to be cracked and was removed.Patient required hospitalization as another picc line was unable to be immediately placed.

• Brand Name: POWERPICC SV 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: 8371165
• Report Number: 3006260740-2019-00373
• Device Sequence Number: 1346109
• Product Code: LJS
• UDI-Device Identifier: 00801741087103
• UDI-Public: (01)00801741087103
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

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: 1173108D
• Device Lot Number: RECR1551
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/26/2019
• 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: Hospitalization