MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 19G X 19MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refr1907 showed seven other similar product complaint(s) from this lot number.The complaints for this lot number (refr1907) have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported "with port needles, the clamp doesn't close properly, blood flow continues.Patient can bleed out if unnoticed." it was reported this occurred with eight devices.This report addresses the fifth device.

• Brand Name: EZ HUBER 19G X 19MM
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14582079
• Report Number: 3006260740-2022-02069
• Device Sequence Number: 5516909
• Product Code: FPA
• UDI-Device Identifier: 00801741089138
• UDI-Public: (01)00801741089138
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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 Model Number: N/A
• Device Catalogue Number: SHG19-75
• Device Lot Number: REFR1907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: Unknown