MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 8 FR. PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT; PORT AND CATHETER ACCESSORIES

Catalog Number	0607780
Medical Device Problem Codes	Fracture (1260); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent a port catheter replacement procedure using the ptfe peel-apart introducer.During the procedure, air allegedly leaked and was unable to replenish blood.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ptfe peel apart percutaneous introducer kit components were returned for evaluations.Visual, microscopic and functional evaluations were performed on the returned device.The complaint sample appeared to be clean.What appeared to be small cracks were observed within the introducer needle hub.No other anomalies were observed.Upon infusion, small leaks were observed from the needle hub.Aspiration was attempted was unsuccessful as water did not fully return into the attached in house syringe.The investigation is confirmed for both reported air/gas in device and identified fracture issues.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (device, component, method, result, conclusion) 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
A patient underwent a port catheter replacement procedure using the ptfe peel apart introducer.During the procedure, air allegedly leaked and was unable to replenish blood.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: 8 FR. PTFE PEEL-APART PERCUTANEOUS INTRODUCER KIT
• Common Device Name: PORT AND CATHETER ACCESSORIES
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24465774
• Report Number: 3006260740-2026-01222
• Device Sequence Number: 9615680
• Product Code: DYB
• UDI-Device Identifier: 00801741038358
• UDI-Public: (01)00801741038358(17)290831(10)REJZ1023
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K860432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Catalogue Number: 0607780
• Device Lot Number: REJZ1023
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown