MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM); 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	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch "the vascular access team nurse attempted insertion under ultrasound guidance of a power glide pro catheter in the patient's right upper arm cephalic vein.The vein was accessed with a needle and good blood return was obtained.The guidewire was advanced without initial resistance, but met resistance while advancing the catheter.The nurse stopped the attempt to advance, but his was ineffective.The device was removed from the patient while extending the catheter to shield the needle as the device was withdrawn.Upon inspection, the catheter appeared to be intact.The entire device was deposited in sharps container in the patient's room.A repeat ultrasound assessment was performed and found vessel difficult to visualize and an abnormal appearance suspicious for foreign object retention.Patient reported no discomfort in the affected area.Overall patient condition was unchanged.Immediately reported my findings and concerns to the intensivist who ordered a follow up ultrasound pf the affected area.The us (ultrasound) of the right upper extremity revealed a thrombosis of the cephalic vein on the right side in the arm and a 3cm segment of the catheter was noted within the cephalic vein.An mri x-ray was performed and confirmed fragment.The patient underwent a venogram by interventional radiologist and the fragment was removed.Fragment retained by hospital." add info received (b)(6) 2022: event information: what type of catheter securement was utilized? the insertion process did not get to the point of securing the catheter.Explant date: same as insertion date.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz1119 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14804544
• Report Number: 3006260740-2022-02428
• Device Sequence Number: 4613060
• Product Code: FOZ
• UDI-Device Identifier: 00801741142703
• UDI-Public: (01)00801741142703
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2022

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 Model Number: N/A
• Device Catalogue Number: F118101T
• Device Lot Number: REFZ1119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Unknown
• Patient Weight: 89 KG