MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 18G 8CM BASIC KIT; INTRAVASCULAR CATHETER

Model Number F118080

Device Problems Kinked (1339); Activation, Positioning or Separation Problem (2906)

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 for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rebs0335 showed seven other similar product complaint(s) from this lot number.All complaints for this lot number (rebs0335) have been reported from the same facility.Samples were discarded.

Event Description

It was reported that the facility has had a total of 8 catheters not deploy properly and kink back on themselves under ultrasound, 180 degrees.There was no patient injury reported, but a delay in patient care as multiple attempts were made.Patient #7.

• Brand Name: PG PRO 18G 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 6848261
• MDR Text Key: 85761792
• Report Number: 3006260740-2017-01560
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110504
• UDI-Public: (01)00801741110504
• 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: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2019
• Device Model Number: F118080
• Device Catalogue Number: F118080
• Device Lot Number: REBS0335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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