MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE 20GX8CM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number F120080T

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

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. A lot history review (lhr) of reep4157 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via medwatch "midline catheter was being placed via ultrasound and when rn unable to get a blood return or positive placement verification with the wire advancement, the catheter was removed. Upon inspection of the catheter, the 2cm tip of the poly catheter was missing. Repeat elbow x-ray taken on (b)(6)2020 and a foreign body noted in the same place. ".

• Brand Name: POWERGLIDE PRO MIDLINE 20GX8CM
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10788539
• MDR Text Key: 214721455
• Report Number: 3006260740-2020-20387
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2022
• Device Model Number: F120080T
• Device Catalogue Number: F120080T
• Device Lot Number: REEP4157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2020
• 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: 11/04/2020 Patient Sequence Number: 1