MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number F318108PT

Device Problems Retraction Problem (1536); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated. Results are expected soon. A lot history review (lhr) of reer0591 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "customer was placing powerglide. When she removed the powerglide, the guidewire was coiled and the catheter was sheared. A piece of the catheter remained in the patient's tissue. They confirmed it was not in the patient's vein. " additional information received 10/27/2020: ¿i inserted the needle, bevel up, into the skin. Visualized the needle inside the vein, obtained blood flash in the chamber, and deployed the guide wire. It made a clicking sound when it reached the bottom of the device. I then tried to deploy the cathlon and it wouldn't advance. I tried once more, and again it wouldn advance. I then attempted to remove the entire device. The guide wire wouldn't retract, so i attempted to remove the whole device, but only the body would pull out. The cathlon pulled out most of the way but was snagged just under the skin at the insertion site. I called the provider to the room, we were able to forcefully remove the cathlon, but when measured, there was approximately 2 cm missing. Device pictured is exactly how the device came out of the patients upper arm, sans the cathlon, which was measured and discarded. ¿.

• Brand Name: FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10809644
• MDR Text Key: 215326563
• Report Number: 3006260740-2020-20405
• Device Sequence Number: 1
• Product Code: FOZ
• 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,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2021
• Device Model Number: F318108PT
• Device Catalogue Number: F318108PT
• Device Lot Number: REER0591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/09/2020 Patient Sequence Number: 1