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

Catalog Number	10387509
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
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 gravity blood set was damaged the following information was provided by the initial reporter with the following verbatim: "i got a complaint from nursing about blood tubing manuf # 10387509 (lot # 24019346) having an issue.The problem is the filter chamber part of the tubing was actually manufactured inverted.I have the affected product but it does have blood in it.This event occurred on 5/30/2024.There was no exposure.I have attached a photo of the item.If you need anything else let me know.Please send return label and container for contaminated item.".
Event or Problem Description
Material# 10387509, batch# 24019346.It was reported by customer that the problem is the filter chamber part of the tubing was actually manufactured inverted.Verbatim: "i got a complaint from nursing about blood tubing manuf # 10387509 (lot # 24019346) having an issue.The problem is the filter chamber part of the tubing was actually manufactured inverted.I have the affected product but it does have blood in it.This event occurred on 5/30/2024.There was no exposure.I have attached a photo of the item.If you need anything else let me know.Please send return label and container for contaminated item.".
Additional Manufacturer Narrative
The customer reported the filter was inverted, and returned a photo and sample of material 10387509, lot 24019346.The sample/photo verifies the complaint of misassembly in the drip chamber filter.The manufacturing site found the root cause for the misassembly to be related to operational error.The failure mode was addressed under a quality notification (b)(6) 2024 which communicated to the production personnel the correct assembly procedure.Device history record review for model 10387509 lot number 24019346 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25jan2024.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 GRAVITY BLOOD 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: 19618904
• Report Number: 9616066-2024-00942
• Device Sequence Number: 14957038
• Product Code: FPA
• UDI-Device Identifier: 10885403234217
• UDI-Public: (01)10885403234217
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• 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): 01/15/2025

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 Catalogue Number: 10387509
• Device Lot Number: 24019346
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown