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

Catalog Number	42100E-07
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the bd iv gravity and secondary sets were missing 2 caps.The following information was provided by the initial reporter: we have noticed a lot of pn 42100e-07 is missing 2 caps on the stopcocks.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: one sample was submitted for quality investigation.The customer complaint of misassembly was verified by visual inspection of the submitted sample.Examination of the sample show that the caps on the stopcocks of the construction are missing.A device history record review for model 42100e-07 lot number 22079262 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10dec2019.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this issue is an error during manufacturing that did not add the tubing caps to the stopcocks in the infusion line.An investigation was conducted at the manufacturing location and a quality notification was issued to correct the issue.
Event or Problem Description
It was reported by the customer that the bd iv gravity and secondary sets were missing 2 caps.The following information was provided by the initial reporter: we have noticed a lot of pn 42100e-07 is missing 2 caps on the stopcocks.

• Brand Name: BD IV GRAVITY AND SECONDARY SETS
• 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: 15663919
• Report Number: 9616066-2022-01605
• Device Sequence Number: 20450813
• Product Code: FPA
• UDI-Device Identifier: 10885403220609
• UDI-Public: 10885403220609
• 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
• 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): 12/06/2022

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: 07/20/2025
• Device Catalogue Number: 42100E-07
• Device Lot Number: 22079262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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