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

Catalog Number	20029E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris medical infusion system administration sets were not able to prime and were leaking.The following was received by the initial reporter: we are having issues with part number 20029e, the micron filter is leaking and this a huge safety concern because a critical med was leaking.
Event or Problem Description
It was reported that the bd alaris medical infusion system administration sets were not able to prime and were leaking.The following was received by the initial reporter: we are having issues with part number 20029e, the micron filter is leaking and this a huge safety concern because a critical med was leaking.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-aug-2023.Investigation summary: total 51 unopened sample(s) received for mat# 20029e for investigation from customer.It was reported by customer that they are having issues with part number 20029e, the micron filter is leaking.Prior to functional testing the set was visually examined for defects and abnormalities.No defects or abnormalities were observed.The set was connected to a 10 ml bd syringe filled with water solution and attempted to be flushed.The fluid pass through the sample and no leakage was replicated through micron filter in all samples so the complaint could not be verified.A device history record review for model 20029e and lot number 22105097 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06oct2022.A device history record review for model 20029e and lot number 22105196 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07aoct2022.A device history record review for model 20029e and lot number 22115352 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19nov2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.The root cause of this complaint could not be determined because the issue could not be replicated on unused samples and no actual sample received.

• Brand Name: BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
• Common Device Name: 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: 17490423
• Report Number: 9616066-2023-01698
• Device Sequence Number: 7246279
• Product Code: FPA
• UDI-Device Identifier: 50885403234864
• UDI-Public: (01)50885403234864
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 20029E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 10/07/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown