MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SEC 20DP W/SS DC LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Model Number 10014881

Device Problems Obstruction of Flow (2423); Improper Flow or Infusion (2954)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that 3 bd sec 20dp w/ss dc low sorb experienced flow issues.The following information was provided by the initial reporter: secondary set flowing drug into primary iv bag.Drug had to be sent back to the pharmacy to be adjusted /spiked under hood (impact: additional cost and time).

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint that the secondary set was flowing drug into primary iv bag could not be verified due to the product not being returned for failure investigation.A device history record review for model 10014881 lot number 22099112 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08sep2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that 3 bd sec 20dp w/ss dc low sorb experienced flow issues.The following information was provided by the initial reporter: secondary set flowing drug into primary iv bag.Drug had to be sent back to the pharmacy to be adjusted /spiked under hood (impact: additional cost and time).

• Brand Name: BD SEC 20DP W/SS DC LOW SORB
• 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: 16018430
• MDR Text Key: 308472798
• Report Number: 9616066-2022-02014
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K790582
• 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,Followup
• Report Date: 01/12/2023

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 Model Number: 10014881
• Device Catalogue Number: 10014881
• Device Lot Number: 22099112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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