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	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported the rn was attempting to place a powerglide pro rt and got to a point where she thought she was in the vein.She advanced the guidewire and it flowed relatively smoothly.When she went to advance the catheter, it wouldn¿t advance.She pulled the catheter back and then tried to retract the wire and it sheared.She stopped pulling it back and sent the patient to interventional radiology to get it removed.The md pulled out the full device and wire and the shearing was then observed.
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 intact.The wire remained in the catheter, with the distal tip protruding from the catheter tip.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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported the rn was attempting to place a powerglide pro rt and got to a point where she thought she was in the vein.She advanced the guidewire and it flowed relatively smoothly.When she went to advance the catheter, it wouldn't advance.She pulled the catheter back and then tried to retract the wire and it sheared.She stopped pulling it back and sent the patient to interventional radiology to get it removed.The md pulled out the full device and wire and the shearing was then observed.

• Brand Name: BASIC KIT 18G X 10 CM WITH BIOPATCH
• 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: 9225521
• Report Number: 3006260740-2019-03301
• Device Sequence Number: 19225756
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 12/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F318107T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention