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

Catalog Number	M120100
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/01/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6355183
• Report Number: 3006260740-2017-00147
• Device Sequence Number: 976622
• Product Code: FOZ
• UDI-Device Identifier: 00801741075322
• UDI-Public: (01)00801741075322(17)180728(10)REAV2240
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2018
• Device Catalogue Number: M120100
• Device Lot Number: REAV2240
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention