MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SMARTSITE NEEDLE-FREE VALVE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2000E

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite needle-free valve had flow issues.The following information was received by the initial reporter in chinese with the verbatim: at 9:20 am on (b)(6) 2023, indwelling needle puncture was performed on the patient, and materials were prepared before operation.The package of the sealed infusion joint without a needle was intact without damage and without air leakage.Within the validity period, after opening the outer package, 10ml was used to pre-charge exhaust gas, but the exhaust gas was not smooth, then the pre-charge was replaced and the exhaust gas was again, and the exhaust gas was still not smooth.Then a new needle-free closed infusion joint was replaced, the exhaust was smooth, and the next operation was carried out for the patient.Physiological response (body temperature: 36.5; breathing: 20 times/min; pulse: 78 beats/min; blood pressure: 116/68mmhg; peripheral blood oxygen saturation: 99%).

Manufacturer Narrative

H.6.Investigation summary: a 2000e china sample was not available for investigation; however, the customer indicated the complaint sample was from lot 23035120.The feedback provided by the customer suggests an occlusion was detected during use of the smartsite device; furthermore the customer appears to indicate the connecting product was a bd product.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 23035120 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the smartsite component in the past 12 months.

• Brand Name: BD ALARIS SMARTSITE NEEDLE-FREE VALVE
• Type of Device: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17848751
• MDR Text Key: 324676725
• Report Number: 9616066-2023-01982
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403238345
• UDI-Public: (01)10885403238345
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E
• Device Lot Number: 23035120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1