MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F S/L PICC WITH STIFFENING STYLET INTERMEDIATE TRAY 30 CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4132100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reaz0596 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported that during insertion, the guidewire was pulled back to 19cm and the catheter was cut at the 20cm mark.Nurse had difficulty inserting the catheter past the introducer, and upon removal the catheter broke around the 10cm mark.No patient injury reported.

• Brand Name: PER-Q-CATH PLUS 2F S/L PICC WITH STIFFENING STYLET INTERMEDIATE TRAY 30 CM
• 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: 7278548
• Report Number: 3006260740-2018-00233
• Device Sequence Number: 16487048
• Product Code: LJS
• UDI-Device Identifier: 00801741035210
• UDI-Public: (01)00801741035210
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 4132100
• Device Catalogue Number: 4132100
• Device Lot Number: REAZ0596
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1