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); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of rees0340 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "we had a recent incident with the powerglide pro midline catheter that needs to be reported for investigation as the tip broke off in the patient. " add info rcvd 09/29/2020: during attempt to insert midline to lue cephalic vein, the catheter was slowly advanced but resistance was felt right away. Pt also complained of pain. Immediately, the entire midline unit was removed from patient¿s arm. Upon assessment of midline needle, it was found that approximately 1 cm of the catheter was missing. Catheter was able to be visualized by this rn within arm tissue using ultrasound machine. Pressure was applied with gauze to the needle insertion site and the tourniquet was left in place. The primary rn was informed right away, as well as the attending md consulted ir for recommendation. Within a few minutes, dr. Returned phone call and spoke to this rn regarding situation and quickly arrived to bedside to assess patient. Dr. Assessed patient¿s arm with ultrasound machine and confirmed 1 cm of catheter was visible within arm. Dr. Released the tourniquet and recommended obtaining a venous doppler study within 24 hours, and to leave the catheter tip where it was. ".

• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10690487
• MDR Text Key: 211728680
• Report Number: 3006260740-2020-20142
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: F120108PT
• Device Lot Number: REES0340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2020
• 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: 10/16/2020 Patient Sequence Number: 1