MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 20G X 0.75" NEEDLELESS Y SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned.
Event or Problem Description
It was reported that the needle can't return blood and the bolus resistance is large.Patient status/ intervention: change new needle.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an occlusion is unconfirmed as the alleged problem could not be reproduced in the returned sample.One 20 g x 0.75 in.Huber plus infusion set with a valved y-site was returned for evaluation.An initial visual observation showed a small among of use residue on the returned sample.An attempt was made to flush both access points of the returned infusion set with a 12 ml syringe of water.The returned sample was found to be patent to infusion and aspiration and no abnormalities were observed in the flow rate of the infusion set.While no occlusion was found in the returned infusion set, possible causes of resistance during infusion include improper placement of the needle of the infusion set in the implanted port device and occlusion within the implanted port and/or catheter.A lot history review (lhr) of reex0808 showed no other similar product complaint(s) from this lot number.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that the needle can't return blood and the bolus resistance is large.Patient status/ intervention: change new needle.

• Brand Name: HUBER PLUS 20G X 0.75" NEEDLELESS Y SITE
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15066333
• Report Number: 3006260740-2022-02809
• Device Sequence Number: 5425700
• Product Code: FPA
• UDI-Device Identifier: 00801741065637
• UDI-Public: (01)00801741065637
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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: 012034NY
• Device Lot Number: REEX0808
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2020
• 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