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

Catalog Number	42103E-07
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd gravity set was damaged.The following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.Pieces breaking off tubing ¿ pictures attached.Customer response: what is the date of event? i was given the tubing last week and was made aware of the issue then.When did you identified the issue? (before or during use) during use.If you identified this issue during use, did it lead to any leak? yes.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that pieces braking off tubing.One photo was submitted for quality investigation.Evaluation of the photo submitted, shows that the distal male luer connector disconnected from the infusion set tubing.The customer complaint of separation was confirmed by evaluation of the submitted photo.Further investigation could not be conducted as the photo is not detailed enough to determine how the luer separated from the tubing.Due to no physical sample, the root cause for the failure could not be determined, however, the manufacturing facility had included new fixtures into the assembly of this product to improve the correct assembly between the tubing and the male luer.A device history record review could not be performed because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.Material#: 42103e-07.Batch number#: unknown.It was reported by customer that pieces breaking off tubing.Verbatim#: rcc received a complaint via email.Pieces breaking off tubing.Customer response: what is the date of event? i was given the tubing last week and was made aware of the issue then.When did you identified the issue? (before or during use) during use.If you identified this issue during use, did it lead to any leak? yes.

• Brand Name: BD GRAVITY 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: 18275287
• Report Number: 9616066-2023-02333
• Device Sequence Number: 7152647
• Product Code: FPA
• UDI-Device Identifier: 50885403225848
• UDI-Public: (01)50885403225848
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 02/28/2024

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 Catalogue Number: 42103E-07
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/05/2024
• 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