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

Catalog Number	37262E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd alaris¿ smartsite¿ extension set from lot 22089380, and 4 sets from an unspecified lot came apart during use.The following information was provided by the initial reporter: "we have had extension sets come apart while in use.I have heard of at least 5 different occurrences.".
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22089380; medical device expiration date: 19-aug-2025; device manufacture date: 18-aug-2022.Medical device lot #: unknown; medical device expiration date: unknown; device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: the customer reported the extension set separated while in use, and returned photos of the incident.The photos help to show the material and lot, as well as two separations on one set, at the male luer and y-site.The complaint is verified, but without the physical sample investigation the root cause is unknown.Device history record review for model 37262e lot number 22089380 as performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.
Event or Problem Description
It was reported that 1 bd alaris¿ smartsite¿ extension set from lot 22089380, and 4 sets from an unspecified lot came apart during use.The following information was provided by the initial reporter: "we have had extension sets come apart while in use.I have heard of at least 5 different occurrences.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16519122
• Report Number: 9616066-2023-00394
• Device Sequence Number: 3290493
• Product Code: FPA
• UDI-Device Identifier: 10885403235276
• UDI-Public: 10885403235276
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 37262E
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown