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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 of guidewire difficulty was confirmed and the cause appeared to be use-related.The product returned for evaluation was one powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter was advanced and the safety mechanism was engaged.A break was observed in the core wire.The coil wire was elongated but appeared intact.The wire tip remained within the catheter.Following wire removal, the weld tip was confirmed to be intact.Microscopic inspection of the wire confirmed that the coil wire was intact.The core wire break exhibited a granular fracture surface.A region of increased luster was observed.The wire exhibited curved shape memory in the vicinity of the break.Inspection of the needle revealed mechanical damage along the proximal edge of the bevel.The wire fracture features and needle bevel deformation were consistent with damage initiated by wire withdrawal against the needle bevel.A lot history review (lhr) of redr3249 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the insertion felt normal until deployment of catheter, rn noticed wire and needle not capping, removed complete device.Unsuccessfully attempted another placement in pt.Other arm.No patient harm.Requested further information regarding unsuccessful placement.On (b)(6) 2019- rn stated, "the first placement (with the catheter with the wire that malfunctioned) was in the patient¿s left brachial vein.The second attempt was in the patient¿s right arm but i was unable to get access into this vein due to patient conditions (hypotension, 3-4+ pitting edema) and not due to another device issue.".

• Brand Name: BASIC KIT 18G X 10 CM WITH GUARDIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9477874
• Report Number: 3006260740-2019-03872
• Device Sequence Number: 13799152
• Product Code: FOZ
• UDI-Device Identifier: 00801741140464
• UDI-Public: (01)00801741140464
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F118107T
• Device Lot Number: REDR3249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1