MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 WINGED INFUSION SET 20G X 1 IN; 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	01/18/2022
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 refv3887 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "there was an incident reported that the winged infusion set 20g 1 huber needle was cracked at the end of the tubing (at the luer).".
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of luer cracks could not be confirmed as the returned products did not reveal any issues corresponding to the alleged event.X59 sealed 20 ga x 1in winged infusion sets were returned for evaluation.All of the sample¿s packaging information indicated lot: refv3887.Microscopic observation of the hubs of all of the sealed samples did not reveal any apparent deformation or non-concentric hubs.No cracks in the material were noted.A 12 ml luer lock syringe was able to be attached and secured to all of the hubs without any resistance or issues.Since no apparent issues were found on the sealed samples from lot: refv3887, the complaint could not be confirmed h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "there was an incident reported that the winged infusion set 20g 1" huber needle was cracked at the end of the tubing (at the luer).".

• Brand Name: WINGED INFUSION SET 20G X 1 IN
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13904541
• Report Number: 3006260740-2022-00967
• Device Sequence Number: 4303854
• Product Code: FMI
• UDI-Device Identifier: 00801741065811
• UDI-Public: (01)00801741065811
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 0604200
• Device Lot Number: REFV3887
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 03/25/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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