MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regq3203 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer via medwatch "describe the event or problem: patient had a powerglide 20ga in his arm that was no longer working, was nonfunctioning.Registered nurse (rn) pulled out the non-working powerglide.Rn inserted the new powerglide in the same vein as the one just removed.Rn felt resistance when advancing the catheter over the needle and guide wire.Rn then withdrew the catheter, guidewire and needle from the patient.Rn noticed the tip of the catheter appeared to be fragmented and the very tip was missing.X-ray did not show the fragment in the arm, but a ct demonstrates linear radiopaque foreign body within the mid medial aspect of the arm measuring about 9 mm in length.This is located in the deep soft tissues immediately adjacent to the basilic vein and is consistent with retained fragmented catheter.After discussion with vascular surgeon about risks and benefits of both taking it out or leaving it in, the patient opted to leave it in." this report addresses the nonfunctioning catheter.

• Brand Name: BASIC KIT 20G X 10 CM WITH BIOPATCH
• Type of Device: 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: 15816313
• MDR Text Key: 307085921
• Report Number: 3006260740-2022-05334
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140532
• UDI-Public: (01)00801741140532
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: F320107T
• Device Lot Number: REGQ3203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 130 KG
• Patient Race: Black Or African American