MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM); SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
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.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that they had an incident this week with a midline product that affected the patient (the line was knotted).Additional information 06/14/2024: midline was inserted into a male patient rt upper arm.Insertion went smoothly.Felt slightly grainy at the very end of sliding the catheter off onto the guide wire.Sharp removed easily.No blood back through catheter when attempted to draw back through 10ml syringe.Attempted to withdraw midline catheter out of patient arm.Catheter was extremely stiff to remove almost as if it was caught on something.The catheter was able to slowly be removed using firm backward force.Near the very end of removal of catheter from patient arm is was very painful for patient.Midline catheter was removed intact but had a tight knot noted in the catheter.No other information was provided.
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.The complaint of a knot in the catheter is confirmed and was determined to be use-related.One 10 cm catheter from a 20 ga powerglide pro was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned catheter.A knot in the catheter was observed toward the distal end of the catheter.A microscopic observation revealed deformation of the catheter in the taper region of the distal end.The knot in the distal end of the returned sample was likely caused by repeated advancement and retraction of the catheter against resistance within the vessel.Evaluation of the returned catheter revealed no potential damage or defect related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that they had an incident this week with a midline product that affected the patient (the line was knotted).Additional information 06/14/2024: midline was inserted into a male patient rt upper arm.Insertion went smoothly.Felt slightly grainy at the very end of sliding the catheter off onto the guide wire.Sharp removed easily.No blood back through catheter when attempted to draw back through 10ml syringe.Attempted to withdraw midline catheter out of patient arm.Catheter was extremely stiff to remove almost as if it was caught on something.The catheter was able to slowly be removed using firm backward force.Near the very end of removal of catheter from patient arm is was very painful for patient.Midline catheter was removed intact but had a tight knot noted in the catheter.No other information was provided.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (10CM)
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 19657351
• Report Number: 3006260740-2024-03450
• Device Sequence Number: 15165740
• Product Code: FOZ
• UDI-Device Identifier: 00801741142673
• UDI-Public: (01)00801741142673(11)231015(17)250331(10)REHW1213
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/11/2024

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F120100T
• Device Lot Number: REHW1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: Other
• Patient Sex: Male