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

Model Number N/A

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6672342
• MDR Text Key: 78589764
• Report Number: 3006260740-2017-00915
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528(17)190228(10)REBP1302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• 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