MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 18G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number F318107T

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

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

Event Date 08/09/2018

Event Type  malfunction  

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recp2041 showed no other similar product complaint(s) from this lot number.

Event Description

The facility reported the following: "sized up vessel, very large, upper arm placement.Accessed vessel with no issues, visualized tip of device during insertion.Centered tip in large vessel.Advanced powerglide pro rt wire w/o resistance, pushed device green wings forward to push catheter off, but unable to advance wings completely.Felt a lot of resistance when pushing wings forward on device.Retracted wings completely, then tried to retract gw -but unable.Pulled everything out as one unit with a lot of resistance.When pulling out wire uncoiled and very wire thin and looped over itself in tissue and broke.Then pulled out remainder gw manually.No pt injury or pain was noted".

Manufacturer Narrative

The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was extended and the safety mechanism was engaged.The guidewire exhibited a complete break in the core wire.The coil wire was elongated.The proximal end of the coil wire was detached from the core wire.Microscopic inspection of the broken wire fragment revealed that the weld tip was intact.Inspection of the break in the core wire revealed a granular fracture surface.The fracture exhibited a region of increased luster.Curved shape memory was observed in the vicinity of the break.Inspection of the needle bevel outward flaring deformation along the proximal edge.The region of increased luster in the core wire and the needle bevel damage were consistent with wire damage initiated by withdrawal against the needle bevel.The catheter damage was also consistent with guidewire withdrawal.The blood residue indicated that damage occurred during attempted device insertion.A lot history review (lhr) of recp2041 showed no other similar product complaint(s) from this lot number.

Event Description

The facility reported the following: "sized up vessel, very large, upper arm placement.Accessed vessel with no issues, visualized tip of device during insertion.Centered tip in large vessel.Advanced powerglide pro rt wire w/o resistance, pushed device green wings forward to push catheter off, but unable to advance wings completely.Felt a lot of resistance when pushing wings forward on device.Retracted wings completely, then tried to retract gw -but unable.Pulled everything out as one unit with a lot of resistance.When pulling out wire uncoiled and very wire thin and looped over itself in tissue and broke¿then pulled out remainder gw manually.No pt injury or pain was noted".

• Brand Name: BASIC KIT 18G X 10 CM WITH BIOPATCH
• 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: 7839786
• MDR Text Key: 119154474
• Report Number: 3006260740-2018-02340
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F318107T
• Device Catalogue Number: F318107T
• Device Lot Number: RECP2041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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