MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 20G, 10CM W/ BASIC TRAY; INTRAVASCULAR CATHETER

Catalog Number M120100

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reav2240 showed no other similar product complaint(s) from this lot number.

Event Description

Per sales representative, facility reported that one of their nurses that who is picc line certified and competent in midline insertions, attempted to place a 20g powerglide midline in one of their er patients.The insertion was under ultrasound guidance by a licensed ultrasound tech.It was successful with the imaging showing the needle and the deployed guidewire within the lumen of the vein.This was witnessed by the nurse, the tech and the er physician.At the last point of advancing the catheter, the nurse encountered some resistance, and in her words, ¿felt something wasn¿t right¿.The nurse was unable to detach the catheter from the needle.The nurse attempted to remove the whole midline as a unit from the patient¿s arm.It then sheared off approximately 8 cm.An x-ray was performed and it was found that there was approximately 8 cm of catheter in the subcutaneous portion of the patient¿s arm.No patient harm was reported.

• Brand Name: POWERGLIDE MIDLINE CATHETER 20G, 10CM W/ BASIC TRAY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6355183
• MDR Text Key: 68212471
• Report Number: 3006260740-2017-00147
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741075322
• UDI-Public: (01)00801741075322(17)180728(10)REAV2240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: M120100
• Device Lot Number: REAV2240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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): Required Intervention