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

Catalog Number	10014914
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2023
Type of Reportable Event	Malfunction
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
It was reported that bd alaris syringe module syringe administration set was occluded the following information was received by the initial reporter with the verbatim: description as reported : microbore tubing - unable to prime.The reported product event occurred while in use with a patient but no harm was caused.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
The customer reported the set would not prime and returned one used sample of material #: 10014914 batch #: 23085440.The set was visually examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water with a bd 10 ml syringe and the occlusion was verified.Upon closer inspection, the male luer tip was clogged with a dusty white substance.Even when the luer was attempted to be cleaned out with a needle, the occlusion remained.The device was manufactured at north america molding center (namc).The likely root cause defined by namc for chalky white substance is that this occurred due to inadequate cleaning and the mold needing further cleaning and polishing activities.A quality alert was posted at the press to remind operators of proper cleaning and polishing activities.The defect appears to be isolated to this one batch, and the defect will be monitored through quality notifications and complaint trending.Device history record review for model 10014914 lot number 23085440 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23aug2023.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.Should there be any additional questions as it relates to this (b)(4), please contact your sales support representative, (b)(4).

• 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: 18536845
• Report Number: 9616066-2024-00035
• Device Sequence Number: 6676220
• Product Code: FPA
• UDI-Device Identifier: 10885403233906
• UDI-Public: (01)10885403233906
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/10/2024

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
• Operator of Device: Other
• Device Expiration Date: 08/17/2026
• Device Catalogue Number: 10014914
• Device Lot Number: 23085440
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown