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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of recv0748 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a powerglide pro midline catheter 20 ga wire broke off in patient.It was stated patient was unharmed and all parts were removed.
Additional Manufacturer Narrative
The information provided by bd 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 bd.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 an uncoiled 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 safety mechanism was engaged over the needle tip and the catheter was detached from the assembly.Usage residues were observed throughout the sample.The guidewire exhibited breaks in both the inner core and outer coil wires 3.5cm from the distal tip.The coil wire was not elongated.Microscopic inspection of the guidewire revealed curved shape memory in the vicinity of the breaks.The fracture surfaces were granular and the core wire fracture surface exhibited a region of increased luster.Inspection of the needle bevel revealed mechanical damage along the proximal edge.The break characteristics and needle damage were consistent with damage initiated by retraction of the wire against the needle bevel, followed by tensile (pulling) stress.The guidewire should not be retracted following advancement but should instead be withdrawn with the needle as a unit.A lot history review (lhr) of recv0748 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a powerglide pro midline catheter 20 ga wire broke off in patient.It was stated patient was unharmed and all parts were removed.
Additional Manufacturer Narrative
Labeled for single use - correction.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 an uncoiled 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 safety mechanism was engaged over the needle tip and the catheter was detached from the assembly.Usage residues were observed throughout the sample.The guidewire exhibited breaks in both the inner core and outer coil wires 3.5cm from the distal tip.The coil wire was not elongated.Microscopic inspection of the guidewire revealed curved shape memory in the vicinity of the breaks.The fracture surfaces were granular and the core wire fracture surface exhibited a region of increased luster.Inspection of the needle bevel revealed mechanical damage along the proximal edge.The break characteristics and needle damage were consistent with damage initiated by retraction of the wire against the needle bevel, followed by tensile (pulling) stress.The guidewire should not be retracted following advancement but should instead be withdrawn with the needle as a unit.A lot history review (lhr) of recv0748 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a powerglide pro midline catheter 20 ga wire broke off in patient.It was stated patient was unharmed and all parts were removed.

• Brand Name: PG PRO 20G 10CM BASIC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8189575
• Report Number: 3006260740-2018-03669
• Device Sequence Number: 2266850
• Product Code: FOZ
• UDI-Device Identifier: 00801741110535
• UDI-Public: (01)00801741110535
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2019
• Report Date (Section F): 12/01/2018

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: N/A
• Device Catalogue Number: F120100
• Device Lot Number: RECV0748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/11/2019; 01/11/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/23/2019; 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/01/2018