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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redy3869 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during insertion resistance was met when threading.Then the inserter removed the entire unit and the wire and catheter was sheared.
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 two 20ga x 10cm powerglide pro midline catheters.Biological residues were observed throughout the first sample (sample 1).The catheter terminated 8.2cm from the molded joint.The tip appeared irregular.Microscopic inspection of sample 1 confirmed an irregular break profile.The fracture surface was partially granular and partially glossy.A longitudinally aligned score mark was observed on the inside surface of the catheter leading into the glossy region of the fracture.Also received was the placement housing with the safety mechanism engaged.Usage residues were observed throughout the sample.The guidewire was not engaged with the advancer.Microscopic inspection of the guidewire advancer revealed wear marks on the coupler region.Inspection of the guidewire revealed it to be intact.The catheter break features were consistent with shearing the catheter against the needle tip.Such damage can occur if the catheter is drawn against the needle tip or if the needle is re-inserted 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.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ the guidewire was not sheared, as indicated in the event description, but rather had become disengaged from the advancer, likely to attempted advancement against resistance, such as into tissue.It appeared that initial placement was attempted against resistance, and subsequent retraction of the catheter caused it to be sheared against the needle tip.Sample 2 was unremarkable to physical, functional and microscopic analysis.A lot history review (lhr) of redy3869 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during insertion resistance was met when threading.Then the inserter removed the entire unit and the wire and catheter was sheared.

• 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: 9979797
• Report Number: 3006260740-2020-01439
• Device Sequence Number: 13972485
• Product Code: FOZ
• UDI-Device Identifier: 00801741110535
• UDI-Public: (01)00801741110535
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: F120100
• Device Lot Number: REDY3869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1