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

Catalog Number	8881135609
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd pca set had foreign matter the following information was received by the initial reporter with the following verbatim it was reported by customer that multiple bags within each case had a greasy/oily residue on the inside.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported oily/greasy residue on the syringes, and returned photo evidence of the issue.The photos are of material 8881135609, lot 2432405464.Upon initial visual examination, the sets verified the failure, and the complaint of foreign matter is confirmed.The customer reported finding the issue and rejecting 100% of cases received of this product, for 32 cases in total.The supplier of the syringes has been notified and a case has been created to address the issue.The supplier also handles the device history record review for this product.

• Brand Name: BD PCA 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): BECTON DICKINSON; 1 becton drive; parque industrial el florido; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22974499
• Report Number: 9616066-2025-02669
• Device Sequence Number: 9370737
• Product Code: FPA
• UDI-Device Identifier: 20192253030652
• UDI-Public: (01)20192253030652
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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 Catalogue Number: 8881135609
• Device Lot Number: 2432405464
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown