MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER; 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)
Date of Event	10/27/2019
Type of Reportable Event	Malfunction
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 sheared catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 8cm powerglide pro rt midline catheter assembly.The sample was received with the catheter advanced and the safety mechanism engaged.Usage residues were observed throughout the sample.Curved shape memory was observed throughout the catheter.Complete breaks were observed in both the coil and core wires.A longitudinally aligned split was observed in the catheter, approximately 1.5cm from the distal tip.Microscopic inspection of the needle revealed mechanical damage along the proximal edge of the bevel.Inspection of the core wire break site revealed a granular fracture surface with one region of increased luster.Curved shape memory was observed in the vicinity of the break.Inspection of the catheter split revealed a sharply defined irregular fracture surface.The fracture surface exhibited a glossy fracture surface.The wire break features and needle bevel damage were consistent with guidewire retraction against the needle bevel, likely at a sharp insertion angle.The catheter fracture features were consistent with perforation by the introducer needle tip.This can occur if the catheter is retracted against the needle and if the needle is further advanced following catheter advancement.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.¿ a lot history review (lhr) of redu0649 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the powerglide pro rt midline catheter sheared or broke.11/8/2019- additional information received stated, "catheter was inserted with no noticeable resistance.Threaded guidewire and catheter and it went fine.Tried to aspirate and got no blood return.Tried to flush and could not flush.Pulled catheter out of patient and the guidewire had broken off somehow and was inside the catheter.".

• Brand Name: FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER
• 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: 9341823
• Report Number: 3006260740-2019-03585
• Device Sequence Number: 2852769
• Product Code: FOZ
• UDI-Device Identifier: 00801741140679
• UDI-Public: (01)00801741140679
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 11/19/2019

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 Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: F320088PT
• Device Lot Number: REDU0649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1