MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/GUARDIVA; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 deformed catheter was confirmed.The product returned for evaluation was one 3fr s/l provena powermidline catheter.Usage residues were observed throughout the sample and a needleless injection cap was attached to the luer and a statlock catheter stabilization device was attached to the suture wings.Kinks were observed in the catheter near the 3cm and 4cm depth markings.Microscopic inspection of the sample confirmed the presence of kink impressions.The catheter wall thickness was measured at multiple points using a digital microscope and found to be within manufacturing specifications.The permanent kink impressions were consistent with sharp bending of the catheter shaft.The locations of the kinks suggested that catheter insertion, maintenance and securement techniques likely contributed.A lot history review (lhr) of redu3809 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that provena midline catheter was removed in less than 3 days after insertion due to malfunctioning.Upon removal, the catheter was curved which confirmed line function issue based on the patients arm position.The line was in an intensive care patient.(b)(6) 2020: evaluation found the catheter was kinked.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/GUARDIVA
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10846433
• Report Number: 3006260740-2020-03582
• Device Sequence Number: 18972472
• Product Code: PND
• UDI-Device Identifier: 00801741153969
• UDI-Public: (01)00801741153969
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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
• Report Date (Section B): 11/16/2020

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 Model Number: N/A
• Device Catalogue Number: S4153108DG
• Device Lot Number: REDU3809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1