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

Catalog Number 2000E CHINA

Device Problem Blocked Connection (2888)

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

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

2000e china 510k: this is an international code - the model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is 2000e.The 510k number provided is for the domestic similar product: k061285.Initial reporter phone #: (b)(6).Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a 2000e china product was not available for investigation; and the lot number was not provided in this instance.The feedback provided by the customer indicates a complete occlusion was detected during use of the smartsite device; however, no further information was available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.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.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 (appendix 1 & 2).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.

Event Description

It was reported that the bd smartsite¿ needle-free connector could not flow successfully.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital with the diagnosis of "acute pancreatitis".At 10:45 on (b)(6) 2022, when the central venous tube was indwelled and connected to the needle-free sealed infusion connector, it was found that the liquid could not flow successfully, and then another needle-free sealed infusion connector was replaced.Normal use.

• Brand Name: BD SMARTSITE¿ NEEDLE-FREE CONNECTOR
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15794687
• MDR Text Key: 307591456
• Report Number: 9616066-2022-01722
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2000E CHINA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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