MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 20G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redx2363 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after insertion of the catheter, the catheter sheared and the other piece that sheared remained in the patient's arm.Patient was taken for xray and ct scan showed that the sheared piece remained in the patient's arm.Patient is scheduled for surgery today (b)(6) 2020 to remove sheared piece.On 01/30/2020- additional information received stated, "as rn was inserting the powerglide into the patient's vein.Rn received blood return, guided the powerglide into the vein, guide wire was used but met with resistance.Rn retracted the guidewire, readjusted the powerglide to better flow in the vein.Guidewire was pushed again but not met with resistance.Rn insert the rest of the powerglide into the vein.No resistance was met during the insertion, rn pulled the device from patient's arm, as rn pulled the device, the catheter was pulled with it." on 02/03/2020- additional information received stated, " while performing a routine insertion of this device, the staff member engaged the release button that would retract the guidewire assembly and leave the catheter in place in the patient.However, this device failed and when the button was pushed and device withdrawn, the entire kit to include the catheter came out.The rn was astute and immediately noticed that the catheter was now approximately 5 cm shorter and a piece had been retained.The issues was immediately escalated through channels.An ultrasound was performed and confirmed the tip was retained.Consult made with our interventional radiologist performed and the object was removed.".

• Brand Name: BASIC KIT 20G X 10 CM WITH BIOPATCH
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9732435
• Report Number: 3006260740-2020-00573
• Device Sequence Number: 2401710
• Product Code: FOZ
• UDI-Device Identifier: 00801741140532
• UDI-Public: (01)00801741140532
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: F320107T
• Device Lot Number: REDX2363
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 68