MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER 4F MAXIMAL BARRIER TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3274108D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reax1145 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported during insertion of the picc line the rn noted the wire was kinked at the tip.Another set kit was opened and used.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a kinked stylet is confirmed; however the exact cause is unknown.One 4 fr dual lumen powerpicc sv with a t-lock and stiffening stylet inserted was returned for evaluation.An initial visual observation showed approximately 37.5 cm of the proximal end of the stylet was protruding from the t-lock.Multiple bends were observed in the stylet beginning about 4 cm proximal to the t-lock and ending about 1 cm proximal to the t-lock.The t-lock was observed to not be locked on the luer connector hub of the red lumen.The stylet was gently pulled out of the red lumen and some slight resistance was felt.The distal tip of the stylet was observed to be severely bent.A microscopic observation revealed the coiled wire of the stylet was broken near the distal tip and the fracture was observed to be angled with an uneven and mostly granular surface texture.No unraveling of the coiled wire was observed near the break in the coiled wire.While the exact cause of the break in the coiled wire of the stylet is unknown, possible causes include twisting, bending, and/or excessive manipulation of the stylet and instrument damage.A lot history review (lhr) of reax1145 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported during insertion of the picc line the rn noted the wire was kinked at the tip.Another set kit was opened and used.

• Brand Name: POWERPICC SV CATHETER 4F MAXIMAL BARRIER TRAY (DUAL-LUMEN)
• 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: 8044283
• Report Number: 3006260740-2018-03162
• Device Sequence Number: 11209471
• Product Code: LJS
• UDI-Device Identifier: 00801741027833
• UDI-Public: (01)00801741027833
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 3274108D
• Device Catalogue Number: 3274108D
• Device Lot Number: REBT1346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1