MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BASIC KIT 20G X 8 CM WITH GUARDIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.Device not returned.
Event or Problem Description
It was reported, writer was placing a midline on patient.Writer was using powerglide pro 20g 8cm.Ref f120087t lot regw1332 writer placed midline in vessel, advanced the guidewire with no resistance, then proceeded to advance the catheter but met resistance once about 4 cm was advanced.Writer removed the midline, and the patient was found to still have about 4 cm of catheter still in their arm.Md notified.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged midline catheter was confirmed.The product returned for evaluation was 20ga x 8cm powerglide pro midline catheter.The catheter had been advanced and was separated from the housing assembly.The safety was engaged over the needle tip.Usage residues were observed throughout the catheter, which was returned in two segments which shared a complete break approximately midway along the catheter shaft.The break in the catheter shaft exhibited a tapered profile.Microscopic inspection of the break surface revealed a partially glossy and partially granular fracture surface.A longitudinally aligned scoring mark was observed on the inside surface of the catheter shaft leading into the fracture site.Microscopic inspection of the distal end of the catheter revealed the edges of the tip to be buckled inward.The fracture features were consistent with damage caused by contact between the catheter shaft and the tip of the introducer needle.Such damage can occur if the catheter is withdrawn onto the needle shaft and if the needle is re-inserted into the catheter following catheter advancement.Further, the deformation of the catheter tip suggested that some resistance may have been encountered during device insertion which may have contributed to manipulation/withdrawal of the catheter following initially attempted insertion.
Event or Problem Description
It was reported, writer was placing a midline on patient.Writer was using powerglide pro 20g 8cm.Ref f120087t lot regw1332 writer placed midline in vessel, advanced the guidewire with no resistance, then proceeded to advance the catheter but met resistance once about 4 cm was advanced.Writer removed the midline, and the patient was found to still have about 4 cm of catheter still in their arm.Md notified.

• Brand Name: BASIC KIT 20G X 8 CM WITH GUARDIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17008213
• Report Number: 3006260740-2023-02123
• Device Sequence Number: 7031980
• Product Code: FOZ
• UDI-Device Identifier: 00801741140471
• UDI-Public: (01)00801741140471
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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 Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F120087T
• Device Lot Number: REGW1332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown