MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 20350E

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 the bd alaris medical infusion system administration sets is flimsy.Report 1 of 3.The following was received by the initial reporter: the tubing is very flimsy and creates a lot of issues with pump alarms during infusions.The same tubing noted in pictures comes packaged kinked and requires straightening before use, don¿t know if it¿s due to heat exposure or just a packaging issue.The filter shown in the pictures even after line straightening still would not flow the medication through it.I think it has glue clogging the line at the seam where line connects to the actual filter.Had same issue with a filter set a couple days ago, but was able to get it flowing after some vigorous shaking.Primary tubing sets: i have been receiving a lot of them with kinks at the base of the drip chamber in the tubing that require straightening by squeezing the kink out before use.Yesterday after attempting to squeeze the tubing and i still couldn¿t get flow through the tubing, so discarded that set and opened a new one.That was atypical, usually they can be straightened.But never the less it¿s a pain having to straighten kinks in tubing before use.

Event Description

It was reported that the bd alaris medical infusion system administration sets is flimsy.Report 1 of 3.The following was received by the initial reporter: the tubing is very flimsy and creates a lot of issues with pump alarms during infusions.The same tubing noted in pictures comes packaged kinked and requires straightening before use, don¿t know if it¿s due to heat exposure or just a packaging issue.The filter shown in the pictures even after line straightening still would not flow the medication through it.I think it has glue clogging the line at the seam where line connects to the actual filter.Had same issue with a filter set a couple days ago, but was able to get it flowing after some vigorous shaking.Primary tubing sets: i have been receiving a lot of them with kinks at the base of the drip chamber in the tubing that require straightening by squeezing the kink out before use.Yesterday after attempting to squeeze the tubing and i still couldn¿t get flow through the tubing, so discarded that set and opened a new one.That was atypical, usually they can be straightened.But never the less it¿s a pain having to straighten kinks in tubing before use.

Manufacturer Narrative

Investigation summary: two photos were provided by the customer for quality investigation.The customer complaint of loose component could not be verified by inspection.Evaluation of the photos provided show kinks in the tubing; however, the photos do not show connection issues or flow issues due to the kinks observed.A device history record review for model 20350e lot number 23019262 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18jan2023.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.

• Brand Name: BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17431065
• MDR Text Key: 320221064
• Report Number: 9616066-2023-01586
• 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: K022209
• 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: 08/31/2023

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: Health Professional
• Device Catalogue Number: 20350E
• Device Lot Number: 23019262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/31/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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