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

Model Number	N/A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
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 catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 8cm powerglide pro midline catheter.Usage residues were observed throughout the sample.The catheter terminated 5.7cm from the molded joint.The distal break exhibited a tapered profile.Microscopic inspection of the distal tip of the catheter revealed sharp fracture features.The edges were partially glossy and striated.The cross-section was elliptical.The fracture features were consistent with catheter damage caused by retraction against the needle bevel.Additionally the event description states ¿they pulled back on the catheter which we are assuming may have been perforated by the needle.¿ 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.¿ a lot history review (lhr) of reds3505 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported, "powerglide was placed with observation from an experienced lines team member.Patient was in the icu and had multiple spasms which would cause him to jerk sporadically.The line was being placed with the patient having multiple jerking moments, the wire threaded fine, but they met resistance with the catheter.They pulled back on the catheter which we are assuming may have been perforated by the needle.They then pulled the entire device together without much force and that¿s when they noticed approx.2 cm¿s missing from the catheter tip.They immediately called for ultrasound which showed the tip in the tissue vs.The vein.A dr.Determined it is better to leave it since it is in the tissue and will not migrate.No further intervention was necessary.Patient is still in the hospital.".

• Brand Name: PG PRO 20G 8CM BASIC KIT
• 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: 9261948
• Report Number: 3006260740-2019-03411
• Device Sequence Number: 19346655
• Product Code: FOZ
• UDI-Device Identifier: 00801741110528
• UDI-Public: (01)00801741110528
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120080
• Device Lot Number: REDS3505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other