MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/15/2017
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 reax0261 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
While preparing for the picc procedure , it was found that the guidewire was cut and could not be used for the procedure.
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 damaged guidewire was confirmed, and the damage appears to be use related.It was reported that the guidewire was cut and could not be used for the procedure.One 0.018¿ x 135cm guidewire was returned for investigation.The guidewire was received in its hoop.There was a break in the blue tip straightener at the transition between the tapered tip and the stem that is inserted in the hoop.A clear brittle material, which appeared to be adhesive, was found around the break in the tip straightener and the hoop.Dislocations were observed in the coil wire 1.2cm from the distal tip of the guidewire.What could be residual adhesive was observed on the coil wire.A tactual investigation confirmed that the guidewire was intact.The weld tip was not broken.Both the tip straightener and guidewire may have been damaged at the same time and it appears that the guidewire and hoop were damaged during use.A lot history review (lhr) of reax0261 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
While preparing for the picc procedure, it was found that the guidewire was cut and could not be used for the procedure.

• Brand Name: POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6847268
• Report Number: 3006260740-2017-01552
• Device Sequence Number: 68346
• Product Code: LJS
• UDI-Device Identifier: 00801741027673
• UDI-Public: (01)00801741027673
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

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: 04/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 3175135
• Device Lot Number: REAX0261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/09/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1