MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 8 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Malposition of Device (2616)

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

Event Date 04/06/2019

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint an ¿unraveled¿ guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and the safety mechanism was engaged.The guidewire core wire was broken and the coil wire was elongated.The weld tip was intact.The core wire exhibited curved shape memory near the break site.Microscopic inspection of the break in the core wire revealed a granular fracture surface.A region of increased luster was observed.The break exhibited a tapered profile.Following removal of the safety mechanism, inspection of the needle bevel revealed mechanical damage along its proximal edge.The wire break characteristics and needle damage were consistent with damage initiated by withdrawing the wire against the needle bevel at a sharp angle.Such damage can occur if insertion is attempted a steep angle and the wire is withdrawn against the introducer needle.A lot history review (lhr) of recx1448 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that powerglide was inserted by writer into patient's left basilic vein with ultrasound.After catheter was deployed and needle removed the guidewire "unraveled" and the tip became lodged in the mid section of the catheter thus pulling the whole catheter back out of the vein.Pressure was held and homeostasis to the vein was achieved.

• Brand Name: FULL KIT 18G X 8 CM WITH GUARDIVA AND PROBE COVER
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8617233
• MDR Text Key: 145487349
• Report Number: 3006260740-2019-01416
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140556
• UDI-Public: (01)00801741140556
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: F118088PT
• Device Lot Number: RECX1448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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