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 refu1334 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (refu1334) 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 four devices.This report addresses the first device.
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of defective clamps was inconclusive because the returned samples all appeared to be unused lot samples.The product returned for evaluation was four 19ga x 19mm ez huber safety infusion sets.The samples were all received in their original sealed packages.The clamps appeared well formed and unremarkable.Microscopic inspection of the samples was unremarkable.Attempts to infuse water through the samples using a 12ml syringe revealed all four samples to be patent to infusion and aspiration without the clamps engaged.Attempts to infuse and aspirate through the samples with the clamps engaged were unsuccessful.The clamps all appeared to function as intended.No deficiencies were discovered during evaluation of the returned samples; however, the sealed state of the packages indicated that the samples were not the originally implicated device(s).Consequently this complaint is inconclusive at this time.H3 other text : evaluation findings are in section h.11.
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 four devices.This report addresses the first 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: 14581979
• Report Number: 3006260740-2022-02061
• Device Sequence Number: 2058145
• 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,Followup
• Report Date (Section B): 08/12/2022

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: REFU1334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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