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

Catalog Number 1001-110-004

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

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 male ll adaptor had mixed products the following information was received by the initial reporter with the verbatim: 1001-110-004 were mixed with other types of products.

Manufacturer Narrative

The customer reported that 1001-110-004 were mixed with other types of products.There were pictures provided of the mixed product, and upon visual inspection, the complaint was verified.The manufacturing site, north america molding center (namc), found the root cause to be human error in placing the materials into the wrong bin.Namc implemented corrective and preventative actions to fix the issue.This involved adding arrows on the floor for operators, updating the line clearance form, retaining and updating the itr for associates, and adding signs above the bins that match the press number.Namc performed a device history record's review (dhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql's), were manufactured, and released according to applicable procedures and specifications.Quality notification query for the mixed product condition was performed, and there was no history of the defect from batch 2291702.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

No additional information was provided.

• Brand Name: BD MALE 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: 18395231
• MDR Text Key: 331676495
• Report Number: 9616066-2023-02438
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 70885403483778
• UDI-Public: (01)70885403483778
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1001-110-004
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1