MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10014918
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris syringe module syringe administration set was damaged the following information was received by the initial reporter with the verbatim: event details: ¿syringe tubing was found to have a hole in it and was leaking the connected infusion into the bed.¿.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional info.
Additional Manufacturer Narrative
The customer reported that the tubing leaked.One sample model 10014918 lot 23085525 was returned for investigation.The set was examined for defects and abnormalities.A cut was observed on the tubing.No other defects or abnormalities were observed.The set was attached to a 10 ml bd syringe filled with water and flushed.The set was leaking from the observed cut.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the damage in the tubing reported by the customer could not be replicated in the production process and no opportunities were found in the manufacturing of the model and affected tubing.Additionally, based on the photo provided by the vh dchu and customer words it seems that the damage was created during the use, due to this, the failure mode was not found to be related to the tijuana manufacturing process.A device history record review for model 10014918 lot number 23085525 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02sep2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18596232
• Report Number: 9616066-2024-00099
• Device Sequence Number: 6660646
• Product Code: FPA
• UDI-Device Identifier: 10885403233944
• UDI-Public: (01)10885403233944
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2024

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
• Operator of Device: Other
• Device Expiration Date: 08/18/2026
• Device Catalogue Number: 10014918
• Device Lot Number: 23085525
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown