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

Catalog Number	20051E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
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 smartsite extension set was leaking.The following information was received by the initial reporter with the following verbatim: the product leaks from an unknown location after use.
Additional Manufacturer Narrative
Investigation result: one 20051e sample was returned without packaging for investigation; the set was filled with residual fluid, and was received alongside a bd posiflush sp 5ml syringe.The customer reported that the affected sample was from lot 23125338 and leaked "from an unknown location after use." the returned sample was subjected to leakage testing in order to replicate the customer's experience; leakage was observed from the smartsite.Upon closer inspection, the smartsite piston was identified to be damaged.The details of this feedback were forwarded to the manufacturing site for investigation.A definitive root cause for the customer's experience could not be determined during the investigation, however they confirmed that the smartsite is assembled by automatic assembly machine which is capable of detecting damage of this nature, and automatically rejecting them to ensure that they do not continue on to subsequent assembly steps.Furthermore the customer confirmed that the leakage was identified at the end of the infusion, therefore it is unlikely that a manufacturing defect contributed to the customer's experience.A review of the production records for lot 23125338 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 20051e product in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE EXTENSION 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: 19975341
• Report Number: 9616066-2024-01126
• Device Sequence Number: 7048101
• Product Code: FPA
• UDI-Device Identifier: 07613203012331
• UDI-Public: (01)07613203012331
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 20051E
• Device Lot Number: 23125338
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown