MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that a catheter was selected for insertion into the right basilic vein.The vein was visualized under ultrasound and accessed successfully.The guidewire advanced without difficulty.However, while advancing the catheter over the needle and guidewire, the patient suddenly flexed both arms forcefully inward.The clinician decided to abort the procedure in response to the abrupt motion.Upon withdrawal, it was noted that the catheter had fractured, leaving a fragment of approximately 3 cm in patient.Catheter fragment retained in patient's arm.Vascular surgery was consulted following catheter fracture.At the time of the consult, it was reported to our team that the surgeon did not recommend immediate removal.Complainant cannot say whether the catheter was ultimately removed.Alternative vascular access was established.
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 catheter break is confirmed but the root cause could not be determined.One photograph of two powerglide pro catheters was returned for evaluation.Inspection of the photograph found that one of the catheters (unit 01) was shorter than the other (unit 02).The distal end of the catheter tubing of unit 01 was deformed, indicating that this was the break site.However, no features of the break could be discerned based on the photo.Unit 02 appeared to have no damage, suggesting that it was placed next to the first unit for the purpose of comparison.Based on the available material for review, the complaint is confirmed but there is insufficient evidence to identify the root cause.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE PRO
• Common Device Name: MIDLINE CATHETER
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23527698
• Report Number: 3006260740-2025-08562
• Device Sequence Number: 13303814
• Product Code: FOZ
• UDI-Device Identifier: 00801741140631
• UDI-Public: (01)00801741140631(11)250121(17)260131(10)REJY1053
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 12/15/2025

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: F220108PT
• Device Lot Number: REJY1053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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