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

Catalog Number	11088483
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified number of bd alaris¿ extension sets leaked from the connection sites during use.The following information was provided by the initial reporter: "i have recently been made aware that our small bore iv extension tubing has been leaking at the connection sites consistently among multiple sets.This issue was as well reported to our cn on night shift by the mri technicians who noted that this issue was noted by other nurses from multiple units in the hospital.We do have some similar tubing with a different lot number that has not given us any issues so i do believe that this is isolated to this particular lot.".
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
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-may-2023.D4: medical device lot #: 23019058.D4: medical device expiration date: 05-jan-2026.H4: device manufacture date: 05-jan-2023.H6: investigation summary 11 samples were received and tested by our quality team.There were 6 lot#23019058 sets which two were used, the rest unused.There were 5 lot#23019035 sets all unused.All sets were tested and there were no issues except for one of the used lot#23019058 sets.This set was occluded at the male luer end which verified the complaint.A microscope was used and there was evidence of excess solvent (medical glue) applied to the junction.This is the root cause of the failure.There was an excess amount of solvent applied during assembly which led to the occlusion and leak realized by customer.A device history record review was performed and there were no relevant production issues or quality notifications with the mat # 11088483 sets of the following lots: 23019035 and 230190583.
Event or Problem Description
It was reported that an unspecified number of bd alaris¿ extension sets leaked from the connection sites during use.The following information was provided by the initial reporter: "i have recently been made aware that our small bore iv extension tubing has been leaking at the connection sites consistently among multiple sets.This issue was as well reported to our cn on night shift by the mri technicians who noted that this issue was noted by other nurses from multiple units in the hospital.We do have some similar tubing with a different lot number that has not given us any issues so i do believe that this is isolated to this particular lot.".

• Brand Name: BD ALARIS¿ 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: 16665823
• Report Number: 9616066-2023-00623
• Device Sequence Number: 20351650
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 05/25/2023

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: Health Professional
• Device Expiration Date: 01/04/2026
• Device Catalogue Number: 11088483
• Device Lot Number: 23019035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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