MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SEC SET NO PORTS W/HANGER DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 11448964

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter second phone# : (b)(6).Investigation summary : exec summary - no physical device samples were returned.No samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.A review of the complaint lot history check was performed and this is the 1st related complaint for (check valve failure) on this lot # 22019129.No non-conformances were raised in association with this type of event for this lot in a period of 12 months concluding all inspections were performed as per the applicable operations and met qc specifications.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - a lot history review for this batch # 22019129 was carried out and no related non conformances were raised in association with these packaged lots concluding all inspections were performed as per the applicable operations and met qc specifications.

Event Description

It was reported that 1 bd sec set no ports w/hanger dehp free had check valve malfunction issues.The following information was provided by the initial reporter : the customer reported that the primary bag mounted on the pole and lowered the secondary bag down below the primary (the entire infusion kit set clamped downstream of the junction between the two kits) to re-fill the secondary.Then raised the secondary bag back above the primary bag (mounted correctly on the pole with an 8â¿쳌 head), we observed rapid backflow from the secondary kit into the primary.This test was repeated multiple times to the same result.This clearly shows that the bcv was malfunctioning and was the root cause of this incident.In the process of this testing, the bcv began to function correctly and is currently preventing backflow.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint of check valve failure could not be verified due to the product not being returned for failure investigation.A device history record review for model 11448964 lot number 22019129 was performed.The search showed that a total of 21,603 units in 1 lot number was built on 18jan2022.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.H3 other text : see h10.

Event Description

It was reported that 1 bd sec set no ports w/hanger dehp free had check valve malfunction issues.The following information was provided by the initial reporter : the customer reported that the primary bag mounted on the pole and lowered the secondary bag down below the primary (the entire infusion kit set clamped downstream of the junction between the two kits) to re-fill the secondary.Then raised the secondary bag back above the primary bag (mounted correctly on the pole with an 8â¿쳌 head), we observed rapid backflow from the secondary kit into the primary.This test was repeated multiple times to the same result.This clearly shows that the bcv was malfunctioning and was the root cause of this incident.In the process of this testing, the bcv began to function correctly and is currently preventing backflow.

• Brand Name: BD SEC SET NO PORTS W/HANGER DEHP FREE
• 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: 15031374
• MDR Text Key: 304509503
• Report Number: 9616066-2022-00881
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• 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: 08/02/2022

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: Health Professional
• Device Catalogue Number: 11448964
• Device Lot Number: 22019129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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