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

Model Number	22003E-07
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero multi-fuse pressure rated extension set with needleless connector experienced defective tubing.The following information was provided by the initial reporter: extension set tubing severely kinked.
Additional Manufacturer Narrative
Initial reported facility name: (b)(6) hospital.Investigation summary: one photo was submitted by the customer.The customer complaint of tubing kinked could be verified based on the pictured submitted by the customer.A device history record review for model mz5309 lot number 21115083 was performed.The search showed that a total of 14,403 units in 1 lot number was built on 01nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo was submitted by the customer.The customer complaint of tubing kinked could be verified based on the pictured submitted by the customer.A device history record review for model mz5309 lot number 21115083 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that the bd maxzero multi-fuse pressure rated extension set with needleless connector experienced defective tubing.The following information was provided by the initial reporter: extension set tubing severely kinked.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo was submitted by the customer.The customer complaint of tubing kinked could be verified based on the pictured submitted by the customer.A device history record review for model: mz5309, lot number: 21115083 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 01nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause for the issue was investigated at the manufacturing facility.The investigation concluded that the root cause for the kink in the tubing is that the slide clamp was activated when the infusion set was shipped.This would have cause the tubing to appear kinked when it was taken out of the packaging.Preventative measures and a quality alert were carried out at the engineering level in order to address the issue.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for additional lot number is as follows: d4.Medical device lot#: 21119801, d4.Medical device expiration date: 11/02/2022, h4.Device manufacture date: 11/02/2021.
Event or Problem Description
It was reported that the bd alaris smartsite extension set experienced occlusion.The following information was provided by the initial reporter: 6/01 - samples submitted for investigation indicate the actual failure mode is occlusion and not tubing kinked.As analyzed will be updated to occlusion.

• 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 ; 8015296192
• MDR Report Key: 14142896
• Report Number: 9616066-2022-00418
• Device Sequence Number: 3986587
• Product Code: FPA
• UDI-Device Identifier: 50885403242043
• UDI-Public: 50885403242043
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 05/17/2022

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 Expiration Date: 11/02/2022
• Device Model Number: 22003E-07
• Device Catalogue Number: 22003E-07
• Device Lot Number: 21119802
• 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: 03/28/2022
• Supplement Date Received by Manufacturer: 04/21/2022; 06/07/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 04/28/2022; 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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