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 Defective Component (2292)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that bd alaris smartsite low sorbing extension set was damaged the following information was received by the initial reporter with the following verbatim i was called to 3 main regarding this product.It is getting cloudy and the tubing is softening⿦ps#41465 customer reply: please confirm whether the tubing looks cloudy, or the fluid is? the tubing was cloudy and soft in the areas of cloudiness compared to the rest of the tubing.What is the date of event? 1/29/24 and 1/30/24 please share the lot number.I believe this is the right lot #(10)23099118.Same in the picture you attached in your previous email to (b)(6).This also happened to the tubing on (b)(6) 2024, but when it was brought to my attention from staff the tubing packaging was already discarded, and trash removed from the patient's room.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.We are not aware of any negative outcome to the patient.There seems to be no negative impact or any that were identified during this time frame.The drip was running on estimated 24 hours till staff noticed the discolored tubing.There were no leakages.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? yes, i still have the tubing in my office.I can either keep or send to your office, (b)(6) hospital (b)(6) please share the captured photo of the event if available.No other photos other than what was taken.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information was provided.Material#: 20350e, batch number#: unknown.It was reported by customer that the tubing is getting cloudy, and the tubing is softening.Verbatim#: rcc received a complaint via email.Email(s) attached.Do you know if there is a problem with this tubing? the item is: 20350e smart site low sorbing extension sets? i was called to 3 main regarding this product.It is getting cloudy and the tubing is softening⿦ps#41465.Customer reply: please confirm whether the tubing looks cloudy, or the fluid is? the tubing was cloudy and soft in the areas of cloudiness compared to the rest of the tubing.What is the date of event? 1/29/24 and 1/30/24.Please share the lot number.I believe this is the right lot #(10)23099118.Same in the picture you attached in your previous email to michelle.This also happened to the tubing on 1/29/24, but when it was brought to my attention from staff the tubing packaging was already discarded, and trash removed from the patient's room.Describe any patient harm, injury, complication or negative outcome that occurred because of the event.We are not aware of any negative outcome to the patient.There seems to be no negative impact or any that were identified during this time frame.The drip was running on estimated 24 hours till staff noticed the discolored tubing.There were no leakages.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? yes, i still have the tubing in my office.I can either keep or send to your office, (b)(6).Please share the captured photo of the event if available.No other photos other than what was taken.

Manufacturer Narrative

It was reported by customer that the tubing is getting cloudy, and the tubing is softening.Three photos were provided by the customer for quality evaluation.One photo provided was of the product packaging and the remaining two photos were of the product in question.The photos of the product that the customer provided, show that there are several locations of the product tubing that appear cloudy.The customer complaint of tubing defective / damaged was verified by evaluation.The failure was reported to the manufacturing facility.Due to no physical sample being provided, a root cause analysis for the issue cannot be conducted and a root cause could not be determined.A device history record review for model 20350e lot number 23099118 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06sep2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.

• 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: 18807222
• MDR Text Key: 336554959
• Report Number: 9616066-2024-00336
• 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: 05/10/2024

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: 23099118
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1