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

Catalog Number 2000E7D

Device Problems Obstruction of Flow (2423); Component or Accessory Incompatibility (2897)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

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 with the verbatim: difficulty during connect syringe and 3 way stopcock.The stopcock they are using is not a bd, they are using dispoflex.Follow up questions: ¿ has there been any patient impact (serious injury, medical intervention, change of treatment required)?no.Please clarify the reported issue i.E., what is the connection issue (unable to connect at all? are fluid blockages occurring?) = unable to connect , difficulty connection.Please describe the set up and/or provide a photograph/diagram to illustrated it = please provide details of the connecting syringe (brand/manufacturer etc.) = luer slip syringes (not bd) and 3 way stopcock (dispoflex).Please confirm if any physical damage or deformity was observed to 2000e7d product? = occlusion , and difficult connection.Please confirm if any leakage occurred? = no.Please confirm what fluid was being administered at the time of the event? =unknown please confirm if any damage was observed to the individual set packaging and/or the outer box it was received in? = no.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: no samples were received for investigation of (b)(4), in which the customer has stated that they experienced an occlusion at the smartsite during access with an unknown syringe.The customer reported the product to be a 2000e7d from lot 1025430.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 1025430 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.Please note, previous complaints for occlusions and flow restrictions have been related to features on the surface of the male luer of the connecting products.These features include flash or a raised edge to the tip of the male luer which have previously been shown to intermittently lead to restricted flow due to them pinching the blue piston of the smartsite and not allowing it to open.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the smartsite product 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18310414
• MDR Text Key: 330280127
• Report Number: 9616066-2023-02384
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 20885403480925
• UDI-Public: (01)20885403480925
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E7D
• Device Lot Number: 1025430
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1