MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 6 IN NON-DEHP MINIBORE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME1227
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s birthday was not provided, (b)(6) 1945 was used based on age of patient a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd 6 in non-dehp minibore extension set the loose connection led to leaks.There was no report of patient impact.The following information was provided by the initial reporter: risk management staff received three reports from the ct technicians that the new iv extension sets, bd maxgaurd extension set were not tight enough and contrast was blowing out iv lines and blowing out of the clave.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of connection issue - leakage could not be verified due to the product not being returned for failure investigation.A device history record review for model me1227 lot number 21065065 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02jun2021.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.
Event or Problem Description
It was reported while using bd 6 in non-dehp minibore extension set the loose connection led to leaks.There was no report of patient impact.The following information was provided by the initial reporter: risk management staff received three reports from the ct technicians that the new iv extension sets, bd maxgaurd extension set were not tight enough and contrast was blowing out iv lines and blowing out of the clave.

• Brand Name: BD 6 IN NON-DEHP MINIBORE 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: 15534483
• Report Number: 9616066-2022-01472
• Device Sequence Number: 7831712
• Product Code: FPA
• UDI-Device Identifier: 10885403236136
• UDI-Public: 10885403236136
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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): 10/17/2022

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: Health Professional
• Device Expiration Date: 06/02/2026
• Device Catalogue Number: ME1227
• Device Lot Number: 21065065
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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 Age: 77 YR
• Patient Sex: Male