MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number F320088T

Device Problems Retraction Problem (1536); Sticking (1597); Failure to Advance (2524)

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

Event Date 04/05/2018

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 rebv1415 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported powerglide pro 8 cm 20 gauge catheter inserted into a patient.After vein accessed, the guidewire advanced with no problem, when the catheter advanced it only advanced halfway.Retracted the catheter and attempted to retract the guidewire but it was stuck in the advanced position.The entire midline pulled out of the patients skin and the guidewire had sheared, uncoiled, and the uncoiled portion was sticking out of the patient¿s skin.Sheared portion of the guidewire was then completely removed.There was no patient injury reported.

• Brand Name: FULL KIT 20G X 8 CM WITH BIOPATCH
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7469913
• MDR Text Key: 106890633
• Report Number: 3006260740-2018-00838
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140723
• UDI-Public: (01)00801741140723
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F320088T
• Device Catalogue Number: F320088T
• Device Lot Number: REBV1415
• 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: 08/01/2017
• 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