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

Catalog Number 2000E

Device Problem Complete Blockage (1094)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd smartsite was occluded the following information was provided by the initial reporter: during use, 9 pieces of connectors exploded, 3 pieces of indwelling needles could not be unscrewed, and 1 piece did not leak liquid.It is necessary to confirm whether there is a product quality problem, a claim needs to be settled, a complaint reply letter is needed, and a complaint acceptance letter is needed.

Manufacturer Narrative

Investigation results: no samples were received for investigation of (b)(4), in which the customer has stated: ¿1 piece did not leak liquid¿.The product in use at the time is reported to be a 2000e china from lot 22045773.No additional information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 22045773 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.Previous complaints for occlusions 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.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 2000e china products in the past 12 months.

Event Description

No additional information.

• Brand Name: BD SMARTSITE
• 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: 18619151
• MDR Text Key: 334243383
• Report Number: 9616066-2024-00155
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: (01)07613203011938
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E
• Device Lot Number: 22045773
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1