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

Catalog Number 20350E

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/10/2023

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 alaris smartsite low sorbing extension set was kinked the following information was received by the initial reporter with the following verbatim tubing is kinking at the filter.Replaced set and tubing kinked again.This happened twice on (b)(6) 2023 and once on (b)(6) 2023.Additional noted in email attached to this pir.

Event Description

No additional info.

Manufacturer Narrative

The customer reported that the tubing is kinked.Four samples model 20350e lot 23059076 were returned for investigation.The sets were examined for defects and abnormalities.One kink was found on one sample just after the filter outlet.No other defects or abnormalities were observed.Three sets were attached to a 10 ml bd syringe filled with water and successfully primed.The customer complaint that the tubing was kinked was verified but this did not impede flow.From the manufacturer's investigation, the potential root cause of kinked tubing could be related to an incorrect coiling of the product, excess of solvent and an incomplete insertion between components by the assembler.The failure mode was addressed under the investigation for the pr 7043075.A quality alert was generated on (b)(6) 2023 to communicate and reinforce the correct assembly process to avoid gaps and incorrect coiling.The medical 15 bushing evaluation was carried out to reduce the solvent in the medical 15 solvent dispenser on (b)(6) 2023.The expander setup with compressed air in the fixtures area was carried out on (b)(6) 2023.Additionally, a work order was created and completed on (b)(6) 2023 to address issues with the medical solvent dispenser.A device history record review for model 20350e lot number 23059076 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE LOW SORBING 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18531806
• MDR Text Key: 333151946
• Report Number: 9616066-2024-00019
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012264
• UDI-Public: (01)37613203012264
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

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: 20350E
• Device Lot Number: 23059076
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1