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

Catalog Number 25206

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that during use with bd specialty extension sets experienced there was a loose connection causing leakage.This is the 4th of 4 reports.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.".

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

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.H3 other text : see h10.

Event Description

It was reported that during use with bd specialty extension sets experienced there was a loose connection causing leakage.This is the 4th of 4 reports.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.".

• Brand Name: BD SPECIALTY EXTENSION SET
• Type of Device: 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17375187
• MDR Text Key: 319787883
• Report Number: 9616066-2023-01505
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233296
• UDI-Public: 10885403233296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 25206
• Device Lot Number: 23039260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1