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

Catalog Number M120100

Device Problems Failure to Advance (2524); Device Or Device Fragments Location Unknown (2590)

Patient Problems Test Result (2695); Device Embedded In Tissue or Plaque (3165)

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 rezi2010 showed no other similar product complaint(s) from this lot number.

Event Description

Per report from distributer, staff was asked by the ed physician to place a midline catheter.Picc staff attempted placement of a 20g/10cm powerglide midline catheter.The vein was visualized by ultrasound and the catheter was inserted.Blood return was noted and the guidewire was advanced without difficulty.It was reported that when attempting to thread the catheter into the vein, the catheter would not advance.The staff withdrew the catheter and the needle and noticed that the end of the catheter appeared shorter.Compared new midline catheter to old one and saw that approximately 2cm of the catheter was allegedly missing, left tourniquet on and notified md.A stat x-ray of the patient arm was ordered and reviewed.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 20G 10CM
• 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: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5332576
• MDR Text Key: 34599102
• Report Number: 3006260740-2015-00611
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741086977
• UDI-Public: (01)00801741086977(17)170828(10)REZI2010
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Catalogue Number: M120100
• Device Lot Number: REZI2010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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