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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that the powerglide catheter sheer.Additional information received on 5/6/2025: arm xray, chest xray, and tte completed without incident.No changes to patients'.Assessment.Discharged on anticoagulants (already required for other health diagnosis).
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 it will be evaluated.A supplemental will be submitted with evaluation results.
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.
Event or Problem Description
Additional information: midline placed in right cephalic vessel.Powerglide would not flushed, upon removal catheter full length not noted.Appears to be sheared with 1-2 cms of catheter tip missing.
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 break in the catheter is confirmed and was determined to be use-related.One 20 ga powerglide pro was returned for evaluation an initial visual observation showed abundant blood residues throughout the returned device.The catheter was returned removed from the needle shaft.The catheter was observed to be broken near the distal end of the catheter shaft.The safety mechanism was observed to be advanced over the needle tip.The safety mechanism was observed to have abundant blood residues inside the safety mechanism.A microscopic observation revealed the break in the catheter shaft to have a 'v' like shape.The fracture edges appeared jagged, and the fracture surface appeared granular.The distal tip of the catheter was not returned for evaluation.No obvious disjointed coils were observed along the guidewire.The characteristics of the break on the returned sample was consistent with damage caused by re-inserting the needle back into the catheter or pulling the catheter back over the needle during the placement process.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE PRO, REINFORCED TIP
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22079298
• Report Number: 3006260740-2025-03338
• Device Sequence Number: 12939406
• Product Code: FOZ
• UDI-Device Identifier: 00801741140723
• UDI-Public: (01)00801741140723(11)240916(17)250930(10)REJU2384
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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,Followup,Followup
• Report Date (Section B): 07/14/2025

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: F320088T
• Device Lot Number: REJU2384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/25/2025; 07/14/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/08/2025; 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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