MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM) CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Component Missing (2306); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of rect0473 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via medwatch while completing a long dwell iv insertion in the patient's left upper arm, the catheter was attempted to be advanced, but it would not advance all the way. There was blood return when pulling back on the syringe, but some resistance was met when flushing the long dwell. Rn decided to pull out the catheter and resistance was met. Rn inspected the long dwell insertion needle and noticed that the guidewire was not present. The long dwell, which was half way out of the patient's arm, was taped to her arm and a chlorhexidine dressing was applied over the insertion site. No other information was provided.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (18G) (10CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8371503
• MDR Text Key: 137204345
• Report Number: 3006260740-2019-00376
• 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

• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: F118100T
• Device Lot Number: RECT0473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2018
• 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: 02/26/2019 Patient Sequence Number: 1