MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 8CM BASIC KIT; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 rebp1302 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
Per sales rep, the facility reported the nurse was placing power glide pro and felt resistance.The rn tried to pull back on device, felt resistance, and saw skin movement around insertion site due to the resistance.It was stated the rn did not want to force the device removal with added pressure so the rn advance the catheter slightly and was successful in removing the device.Once the device was removed from the patient, it was noted that the wire had broken off the device and was inside the catheter.The rn measured the wire against another new device and it was reportedly intact without any part of the wire remaining inside the patient.An x-ray order was placed and a physician was consulted to ensure patient safety.

• Brand Name: PG PRO 20G 8CM BASIC KIT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6672342
• Report Number: 3006260740-2017-00915
• Device Sequence Number: 19036759
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528(17)190228(10)REBP1302
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2017

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: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: F120080
• Device Lot Number: REBP1302
• 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: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1