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

Catalog Number	F120080T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2025
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 it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported trainee clinician sheers off catheter into patient and noted that upon placement difficulty was noted.Clinician stated trainee to remove/retract the midline out of the patient's upper extremity.Both reported that the catheter was forcibly removed and attempted prior to guidewire - this action sheered the catheter into patient subcutaneous tissue not the vascular system.Both stated that needle was advanced instead of retracting it.Command was to retract catheter safety then the guidewire.Trainee error occurred during the retraction process which led to sheering catheter - needle retracted and pushed forward then retracted again.Both clinician and trainee stayed with patient, contacted primary rn, contacted surgery.Surgery assessed and agreed with clinician that the catheter was in the subcutaneous tissue.Or md stated it was safe to remain, and it would be removed in the am.Catheter segment retrieved and removed the morning (b)(6).
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 needle shaft appeared curved, and the guidewire appeared bent just distal of the needle tip.The catheter was returned removed from the needle shaft.The catheter was observed to be broken approximately halfway down the catheter shaft.The safety mechanism was observed to be advanced over the needle tip.A microscopic observation revealed the break in the catheter shaft exhibited a chevron shape.The fracture edges appeared sharp and the fracture surface appeared granular.The distal tip of the catheter appeared misshapen.The catheter break characteristics observed are caused by pulling the catheter against the needle bevel during the insertion process.This may cause a split or a break in the catheter shaft.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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21997531
• Report Number: 3006260740-2025-02997
• Device Sequence Number: 18346669
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666(11)250223(17)260831(10)REKN1468
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 08/31/2026
• Device Catalogue Number: F120080T
• Device Lot Number: REKN1468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2025
• 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