MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refx3455 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the port needle hub leaked at the connection with the iv tubing set.A needle-free connector was applied to the winged infusion set and then connected to the iv tubing set and there was no more leakage.
Event or Problem Description
It was reported that the port needle hub leaked at the connection with the iv tubing set.A needle-free connector was applied to the winged infusion set and then connected to the iv tubing set and there was no more leakage.
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an infusion set hub leak is inconclusive as the photos provided are not a bd product.Two photo samples of a b braun intrafix safeset were provided for evaluation.One of the images shows the safeset packaging label and the other image shows the device within the packaging.The device could not be inspected and the alleged bd product is not shown.Since the reported issue could not be confirmed from the information provided, the complaint could not be confirmed and remains inconclusive at this time.

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 15677400
• Report Number: 3006260740-2022-04135
• Device Sequence Number: 6462471
• Product Code: FMI
• UDI-Device Identifier: 00801741065897
• UDI-Public: (01)00801741065897
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K863606
• 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): 11/04/2022

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 Expiration Date: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 2206220
• Device Lot Number: REFX3455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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 Age: 50 YR
• Patient Sex: Female