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

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Perforation of Vessels (2135)

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The manufacturer has received the sample and is pending evaluation.Results are expected soon.

Event Description

It was reported by customer that patient was in need of iv access.Midline was attempted in left arm in the basilic vein with a 20g/10cm long catheter.Sterile technique was obtained.Midline needle was inserted, guide wire was advanced.Attempt to advanced catheter, however patient yelled in pain.Placement was checked via ultrasound and it was found vein had ruptured.All attempts were stop, guide wire was retracted, catheter was retracted and midline device was taken out, pressure bandage applied.When looking at device it was found a half centimeter was missing.Primary physician was informed and orders were obtained.Patients was informed with room nurse at beside.Additional information received on 28aug2023: the event occurred on (b)(6)2023.Customer did not know if the event involved an urgent or life-threatening medical situation.Customer clarified that it was the catheter that broke.The break was discovered when retracting from the arm and 1/2 cm of catheter was missing.This event did not cause a clinically significant delay in treatment.Patient had no symptoms /complications.Patient had an xray and ultrasound and outcome showed nothing on either diagnostic testing.The missing piece of catheter is currently unaccounted for.Customer reports that the patient did not suffer harm or experience complications from this event.

Event Description

It was reported by customer that patient was in need of iv access.Midline was attempted in left arm in the basilic vein with a 20g/10cm long catheter.Sterile technique was obtained.Midline needle was inserted, guide wire was advanced.Attempt to advanced catheter, however patient yelled in pain.Placement was checked via ultrasound and it was found vein had ruptured.All attempts were stop, guide wire was retracted, catheter was retracted and midline device was taken out, pressure bandage applied.When looking at device it was found a half centimeter was missing.Primary physician was informed and orders were obtained.Patients was informed with room nurse at beside.Additional information received on 28aug2023: the event occurred on 8/22/2023.Customer did not know if the event involved an urgent or life-threatening medical situation.Customer clarified that it was the catheter that broke.The break was discovered when retracting from the arm and 1/2 cm of catheter was missing.This event did not cause a clinically significant delay in treatment.Patient had no symptoms /complications.Patient had an xray and ultrasound and outcome showed nothing on either diagnostic testing.The missing piece of catheter is currently unaccounted for.Customer reports that the patient did not suffer harm or experience complications from this event.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.Based on a review of this information, the following was concluded: the complaint of a broken catheter is confirmed and was determined to be use-related.One 18 ga powerglide pro was returned for evaluation.An initial visual observation revealed abundant blood use residues throughout the returned powerglide pro.It was observed that the guidewire was in place.The tip of the catheter appeared broken with no extra catheter piece returned.A microscopic observation revealed the distal weld tip of the guidewire to be present along the device.No significant deformation was observed along the needle bevel.The distal end of the catheter appeared to have a chevron-shaped break with a granular fracture surface.Because of the shape of the break and the description of the removal of the catheter from the patient, the complaint of a break in the guidewire is confirmed and was determined to be use-related.Possible contributing factors to the difficult insertion of the guidewire include insertion angle, types of tissue the device entered, and other unknown factors.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.

• Brand Name: FULL KIT 20G X 10 CM WITH GUARDIVA AND PROBE COVER
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17729306
• MDR Text Key: 323181865
• Report Number: 3006260740-2023-04037
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

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 Model Number: N/A
• Device Catalogue Number: F120108PT
• Device Lot Number: REHS4784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 51 KG