MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 20G 10CM BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F120100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional 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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.The sample was received with the safety mechanism engaged and usage residues were observed throughout the sample.The coiled section of the guidewire was elongated.A break was evident in the inner core wire.The distal core wire fragment was not returned for evaluation.Microscopic inspection of the break in the core wire revealed a partially granular surface with regions of increased luster.The wire exhibited curved shape memory in the vicinity of the break.Inspection of the break in the coil wire revealed a granular fracture surface and necking in the vicinity of the break.Inspection of the needle revealed deformation along the proximal edge of the bevel.The core wire fracture features were consistent with damage initiated by contact with a hard edge.The needle bevel damage suggested that contact between the wire and the needle bevel initiated the break in the core wire.The coil wire break features were consistent with tensile failure.It appeared that during device insertion, the wire was withdrawn against the needle bevel in a way that caused the needle to partially shear the wire.A lot history review (lhr) of recn1869 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the powerglide wire looked stripped.No additional information provided.

• Brand Name: PG PRO 20G 10CM BASIC
• 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: 7651905
• Report Number: 3006260740-2018-01565
• Device Sequence Number: 11039905
• Product Code: FOZ
• UDI-Device Identifier: 00801741110535
• UDI-Public: (01)00801741110535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/29/2018

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: F120100
• Device Catalogue Number: F120100
• Device Lot Number: RECN1869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1