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

Device Problems Break (1069); Retraction Problem (1536); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): MEDLINE INDUSTRIES; 1001 north tuston ave; santa ana CA 92705
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8800161
• MDR Text Key: 151484519
• Report Number: 3006260740-2019-01988
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741134043
• UDI-Public: (01)00801741134043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1