MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 WINGED INFUSION SET WITH INJECTION SITE 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refp0459 showed three 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 that to connect the syringe or venoclysis equipment to the injection port, to administer any drug infusion, it is necessary to remove the cap from the injection port, which can condition the entry of air to the patient, the above derived from the segment between the port injection and angled needle, it does not have a clamp or safety clip.It was reported this occurred with four devices.This report addresses the second device.
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refp0459 showed three other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that to connect the syringe or venoclysis equipment to the injection port, to administer any drug infusion, it is necessary to remove the cap from the injection port, which can condition the entry of air to the patient, the above derived from the segment between the port injection and angled needle, it does not have a clamp or safety clip.It was reported this occurred with four devices.This report addresses the second device.

• Brand Name: WINGED INFUSION SET WITH INJECTION SITE 20G X 0.75IN
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13550269
• Report Number: 3006260740-2022-00388
• Device Sequence Number: 20098698
• Product Code: FPA
• UDI-Device Identifier: 00801741065866
• UDI-Public: (01)00801741065866
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 2205220
• Device Lot Number: REFP0459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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