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

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	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event the manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx0415 showed two other similar product complaint(s) from this lot number.The complaints for this lot number (refx0415) have been reported from the same facility in mexico.
Event or Problem Description
It was reported there was a solution leak when inserting the port needle (leak).Additional information: the patients who are hospitalized in the oncology area witnessed the event and the nurses report that they did not pass any other medication that could cause greater damage.
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), 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 confirmed but the cause is unknown.A single photograph of a 20g winged infusion set was returned for evaluation.The infusion set appeared to be inserted into a patient¿s port and was being infused with a clear liquid.A small droplet of clear fluid was seen on the needle housing where it connects with the needle.Microscopic examination and functional testing could not be conducted without the physical sample and there were no observable features on the submitted photograph which could aid in identification of 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.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported there was a solution leak when inserting the port needle (leak).Additional information: the patients who are hospitalized in the oncology area witnessed the event and the nurses report that they did not pass any other medication that could cause greater damage.Additional information received: there was no patient harm or need for medical intervention or events with skin/mucosal fluid exposure.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.

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 20G X 1IN
• 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: 15054929
• Report Number: 3006260740-2022-02769
• Device Sequence Number: 4667448
• Product Code: FPA
• 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 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): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 07/19/2022
• 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): No
• 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