MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 18G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recs1730 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the powerglide was being placed in the upper arm when the wire pulled apart and unraveled.
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 a damaged powerglide guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga powerglide pro midline catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned for evaluation.The safety mechanism was engaged over the needle tip.The inner core wire exhibited a complete break.The coil wire was elongated but remained intact.The weld tip was intact.Microscopic inspection of the core wire break site revealed a granular fracture surface.Necking was observed in the vicinity of the break.Inspection of the needle bevel revealed mechanical damage along the proximal edge.The damage comprised regions of outward flaring material, with material flow in the proximal direction.The break characteristics and needle bevel features were consistent with damage initiated by retracting the guidewire against the needle bevel at a sharp angle.The core wire appeared to have subsequently fractured under tensile (pulling) stress.Such events can occur if guidewire retraction occurs in conjunction with a steep insertion angle.A lot history review (lhr) of recs1730 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the powerglide was being placed in the upper arm when the wire pulled apart and unraveled.

• Brand Name: BASIC KIT 18G X 8 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: 8658936
• Report Number: 3006260740-2019-01533
• Device Sequence Number: 11220354
• Product Code: FOZ
• UDI-Device Identifier: 00801741140501
• UDI-Public: (01)00801741140501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/19/2019

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: F318087T
• Device Lot Number: RECS1730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1