MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 8CM FULL; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F220081
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 broken guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 8 cm powerglide pro midline catheter assembly.Usage residues were abundant throughout the sample.The catheter partially overlaid the needle; however, the needle had perforated the catheter approximately midway along its length.The distal end of the guidewire was broken and received loose.The distal wire fragment included in the weld tip.The coil wire was elongated and protruded from the needle bevel.Microscopic inspection of the needle bevel revealed mechanical damage long the proximal edge.Inspection of the break in the core wire revealed a partially granular fracture surface.The break surface exhibited a region of increased luster.Deformation was observed in the vicinity of the break.Inspection of the coil wire break site revealed a granular fracture surface.The needle bevel deformation and guidewire core wire fracture features were consistent with damage caused by retracting the guidewire against the needle bevel.The perforated catheter was consistent with damage caused by retracting the catheter onto the needle tip.A lot history review (lhr) of recr1369 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that midline was attempted to be placed in patient's left upper arm cephalic vein.It was stated, "upon entering midline, guidewire was advanced and started to pop up superiorly to insertion site under the skin.Guide wire was then retracted to abort placement however upon retracting a crack was heard.Guide wire was difficult to retract at this point as well as catheter difficult to retract without resistance being met.Upon us guidance, needle and catheter still in tissue and catheter in vein.Interventional radiology called to bedside.To their discretion, needle tip was not in vein however catheter was in vein.Ir md was called to bedside and took out midline which once pulled showed needle had punctured through catheter and guide wire was tortious.Tip of guide wire actually fell apart from main guide wire while out of patient's arm.Patient had xray of arm to evaluate if any other foreign body in place.Xray confirmed no foreign body.Pt sustained small hematoma that resolved on its own".

• Brand Name: DOT PG PRO 20G 8CM FULL
• 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: 7791636
• Report Number: 3006260740-2018-02083
• Device Sequence Number: 11259225
• Product Code: FOZ
• UDI-Device Identifier: 00801741110672
• UDI-Public: (01)00801741110672
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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: F220081
• Device Catalogue Number: F220081
• Device Lot Number: RECR1369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1