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

Catalog Number	47177E
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: a follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd gravity set disconnected from the patient.The following information was provided by the initial reporter: we do not have the package or the lot number, however, we do have the product that is available to return if needed but we would need a biohazard kit to do so.Please advise.
Event or Problem Description
Material#: 2426-0007.Batch#: unknown.It was reported by the customer that disconnected while on the patient.Verbatim: please see attached photos of item# 47177e that disconnected while on the patient.We do not have the package or the lot number, however, we do have the product that is available to return if needed but we would need a biohazard kit to do so.Please advise.Image also attached.
Additional Manufacturer Narrative
It was reported that the sample separated.One sample model 2426-0007 was returned for investigation.The set was examined for defects and abnormalities.The tubing was separated from the distal y-site.No other defects or abnormalities were observed.Visual inspection under the microscope showed no signs of solvent.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the possible root cause of separation between tubing/y-site (arm) could be related to lack of solvent due to an incorrect solvent application method followed by the assembler.Possible lots were built in (b)(6) 2024 and the separation between tubing and y-site (arm) was addressed under similar complaints where a quality alert was created on (b)(6) 2024 to communicate the failure and reinforce the correct assembly (to avoid gap) and correct solvent application method.A device history record review was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 20440304
• Report Number: 9616066-2024-01476
• Device Sequence Number: 18183620
• Product Code: FPA
• UDI-Device Identifier: 10885403235436
• UDI-Public: (01)10885403235436
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K221327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2025

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: Health Professional
• Device Catalogue Number: 47177E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown