MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD FEMALE LL ADAPTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 1024-156-043

Device Problem Crack (1135)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.D4.Medical device lot #: 2025522.H4.Device manufacture date: 25/jan/2022.D4.Medical device lot #: 2208760.H4.Device manufacture date:27/jul/2022.D4.Medical device lot #: 2208761.H4.Device manufacture date: 27/jul/2022.D4.Medical device lot #: 1132642.H4.Device manufacture date: 12/may/2022.D4.Medical device lot #: 0317918.H4.Device manufacture date:12/nov/2022.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd female ll adaptor was cracked.The following information was received by the initial reporter with the following verbatim: it was reported by the customer that cracks.The intent of this email is to notify icu medical received several customer complaints for cracks the following lots: 2025522; 2208760; 2208761; 1132642; 317918; 2017612.

• Brand Name: BD FEMALE LL ADAPTOR
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18932470
• MDR Text Key: 338668907
• Report Number: 9616066-2024-00426
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 70885403484348
• UDI-Public: (01)70885403484348
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1024-156-043
• Device Lot Number: SEE H.10
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1