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

Model Number F320087T

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

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, at this time, to the manufacturer for evaluation.A lot history review (lhr) of reby2344 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.

Event Description

It was reported the inserting rn met subcutaneous resistance when inserting midline but knew he was going through scar tissue, so persisted.It was stated the rn stopped and pulled the catheter out, it was noted that approximately 2cm of the tip of the catheter was missing.The patient went for a ct and x-ray and it showed multiple implants and stents in the arm.The inserting nurse stated that he may have sheered the catheter on an implant or stent in the patient's arm.

• Brand Name: BASIC 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7447201
• MDR Text Key: 106061401
• Report Number: 3006260740-2018-00766
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140525
• UDI-Public: (01)00801741140525
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: F320087T
• Device Catalogue Number: F320087T
• Device Lot Number: REBY2344
• 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: 11/01/2017
• 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