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

Catalog Number 37262E

Device Problems Crack (1135); Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 03/27/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ smartsite¿ extension set had stiff iv tubing that the clamp cracked through.Additionally, the defective tubing wouldn't connect properly to the iv hub and causing leakage.This occurred with an unspecified number of sets.The following information was provided by the initial reporter: "customer reported that the tubing is stiffer, the clamps have a tendency to crack the stiffer tubing and the hub at the end doesn¿t screw onto the iv hub well, thus leaking problems.At times we go thru two or three of these extension sets.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd alaris¿ smartsite¿ extension set had stiff iv tubing that the clamp cracked through.Additionally, the defective tubing wouldn't connect properly to the iv hub and causing leakage.This occurred with an unspecified number of sets.The following information was provided by the initial reporter: "customer reported that the tubing is stiffer, the clamps have a tendency to crack the stiffer tubing and the hub at the end doesn¿t screw onto the iv hub well, thus leaking problems.At times we go thru two or three of these extension sets.".

Manufacturer Narrative

Investigation summary: a complaint of male luer not connecting properly and tubing being stiffer causing it to crack was received from the customer.No product or photo was returned by the customer.The customer complaint of connection issues, component damage, and tubing defective/ damaged could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 37262e because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION SET
• 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 ; 8448235433
• MDR Report Key: 16729012
• MDR Text Key: 313196048
• Report Number: 9616066-2023-00680
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: 10885403235276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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
• Device Operator: Other
• Device Catalogue Number: 37262E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/03/2023
• 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