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

Catalog Number	11522558
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Date of birth: patient¿s birthday was not provided, (b)(6), 1976 was used based on age of patient.E.4.The initial reporter also notified the fda on (b)(6), 2023.Medwatch report #: (b)(4).D.4 device expiration date: unknown h3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set was damaged.The following information was provided by the initial reporter: customer reported primary iv tubing broke while connected to the patient.The tip of the tubing somehow cracked and the tip was lodged in the microclave cap in the patient's picc line.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of component damage was received from the customer.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The tip of the male luer had broken off.Potential lot numbers were determined using the smartsite ids.The device history review was completed for these potential lots.A device history record review for model 11522558 lot number 23025072 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 07feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 11522558 lot number 23025073 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 16feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 11522558 lot number 23025319 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 21feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 11522558 lot number 23055084 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 11may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The supplier of this component was notified of the defect.The root cause was determined to be due to the automatic assembly process of the revolving male luer connector.The supplier completed a lot review for the potential lots found using the smartsite id, and no records of part damage was found for the potential lots.To prevent this defect in the future, the supplier has implemented a dedicated control and cleaning of the seats where the male luer cone is pressed into the collar with the target to remove plastic fragments that do not permit correct assembly of the male luer cone.The supplier is also evaluating improvements on the grinders of the molding process of the 2 collars involved with the target to add repairs to avoid fragments falling into the bags of the finished collars.
Event or Problem Description
It was reported that the bd alaris pump module smartsite infusion set was damaged.The following information was provided by the initial reporter: customer reported primary iv tubing broke while connected to the patient.The tip of the tubing somehow cracked and the tip was lodged in the microclave cap in the patient's picc line.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17358136
• Report Number: 9616066-2023-01493
• Device Sequence Number: 12497974
• Product Code: FPA
• UDI-Device Identifier: 10885403232305
• UDI-Public: 10885403232305
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 07/26/2023

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: 11522558
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic