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

Catalog Number	25206
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd specialty extension sets experienced a loose connection causing leakage.1 of 3 related files.The following information was provided by the initial reporter: we have had some defective quality issues on item #25206 that have happened in our ob unit.They are telling me that there has been 4 episodes of this item leaking and the patient side does not tighten which has resulted with the fluids on the floor.".
Event or Problem Description
It was reported that the bd specialty extension sets experienced a loose connection causing leakage.1 of 3 related files.The following information was provided by the initial reporter: we have had some defective quality issues on item #25206 that have happened in our ob unit.They are telling me that there has been 4 episodes of this item leaking and the patient side does not tighten which has resulted with the fluids on the floor.".
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of loose component - leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 25206 lot number 23039260 was performed.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.

• Brand Name: BD SPECIALTY 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17342616
• Report Number: 9616066-2023-01476
• Device Sequence Number: 17865976
• Product Code: FPA
• UDI-Device Identifier: 10885403233296
• UDI-Public: 10885403233296
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 08/02/2023

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 Expiration Date: 03/17/2026
• Device Catalogue Number: 25206
• Device Lot Number: 23039260
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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