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	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the product presents a leak between the needle and the extension that connects to the infusion set, which is why the patient had to be punctured again since an erythrocyte concentrate was being transfused.Additional information received by the client on 02.Jul.2022: was the patient able to puncture to complete his treatment? a: it was punctured but it could not be finished applying it.Has there been exposure to blood or chemotherapy to the mucous membranes or the skin of the professional or the patient? a: yes.There was no patient harm or need for medical intervention.The impact was that it is not possible to fully administer the drug and that there is also an increase in costs for the institution.
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refx0415 showed 6 other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in mexico.
Event or Problem Description
It was reported the product presents a leak between the needle and the extension that connects to the infusion set, which is why the patient had to be punctured again since an erythrocyte concentrate was being transfused.Additional information received by the client on 02.Jul.2022: was the patient able to puncture to complete his treatment? a: it was punctured but it could not be finished applying it.Has there been exposure to blood or chemotherapy to the mucous membranes or the skin of the professional or the patient? a: yes.There was no patient harm or need for medical intervention.The impact was that it is not possible to fully administer the drug and that there is also an increase in costs for the institution.
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.He following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the infusion set was inconclusive due to the sample condition.A single photograph of the distal end of a 20g bard winged infusion set was returned for evaluation.The infusion set was laid out on a flat surface with the needle pointing upward.A small droplet of clear fluid was seen on the needle cannula.It could not be determined from the photograph if the droplet of fluid was expelled from the distal end of the needle or came from the reported leak in the infusion set.The observable features on the submitted photographs did not contain enough information to independently confirm the leak or identify a specific root cause for the reported event.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.

• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15028639
• Report Number: 3006260740-2022-02725
• Device Sequence Number: 4557381
• Product Code: FMI
• UDI-Device Identifier: 00801741065897
• UDI-Public: (01)00801741065897
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K863606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: REFX0415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/11/2022
• 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 Sex: Unknown