MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ EXTENSION SET, 1 SMARTSITE¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	22003E-07
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device lot # listed as unknown provided 614338, lot is not associated with medical device catalog # 22003e-07.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd smartsite¿ extension set, 1 smartsite¿ needle-free connector is difficult to attach the saline flush.The following information was provided by the initial reporter: i also found it difficult to attach and it required much more than usual force to attach the saline flush and quite a bit of pressure to get the flush to go through, which then came out the end and showered my top with saline.
Additional Manufacturer Narrative
H6: investigation summary a complaint of a luer lock attachment being defective, causing the syringe not to properly flush was received from the customer.A photo of the sample was provided for investigation.In the photo, the syringe is see to be bent and damaged.The syringe or the connected component in the photo do not match the provided material number.A device history record review could not be performed on model 22003e-07 because the lot number is invalid.Due to a physical sample not being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
It was reported that the bd smartsite¿ extension set, 1 smartsite¿ needle-free connector is difficult to attach the saline flush.The following information was provided by the initial reporter: i also found it difficult to attach and it required much more than usual force to attach the saline flush and quite a bit of pressure to get the flush to go through, which then came out the end and showered my top with saline.

• Brand Name: BD SMARTSITE¿ EXTENSION SET, 1 SMARTSITE¿ NEEDLE-FREE CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15415358
• Report Number: 9616066-2022-01329
• Device Sequence Number: 14149482
• Product Code: FPA
• UDI-Device Identifier: 50885403242043
• UDI-Public: 50885403242043
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: Other
• Device Model Number: 22003E-07
• Device Catalogue Number: 22003E-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown