MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV CATHETER, 3 F SL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of 18kbn221 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "pt was asked to have picc placed in icu for difficult access.Pt is a chronic child but has never had a picc before.Picc team attempted to place picc to right basilic and was able to access vein and thread wire easily as well as dilatate the vein.However; when attempting to place the 3fr to right basilic picc line would not thread past 10cm in right arm.Picc rn attempted to retract picc line and picc line would not retract.After twisting picc line in vessel , picc line was able to be retracted.Upon examining the picc before attempting to thread again picc rn noticed wire protruding from the tip of catheter.Attempted at that time to retract wire at the lumen of the picc and magnet on tip of picc would not retract.Picc rn then attempt to advance wire through tip of picc and when she did a piece of the wire was noted to be broken and fell to the sterile drape.Attempted to advance wire again and another piece also fell onto the sterile drape.That picc kit was then discarded and another 3 fr kit was then used." it was stated that there was no harm to the patient as "picc catheter remained intact and none of the broken wire pieces were retained in the patient.".

• Brand Name: POWERPICC SV CATHETER, 3 F SL, 3CG
• 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: 8800161
• Report Number: 3006260740-2019-01988
• Device Sequence Number: 327593
• Product Code: LJS
• UDI-Device Identifier: 00801741134043
• UDI-Public: (01)00801741134043
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/17/2019

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 Expiration Date: 02/22/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000417B
• Device Lot Number: 18KBN221
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1