MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SYRINGE 50CC LL TIP CONVENIENCE PAK

Catalog Number	309680
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe 50cc ll tip convenience pak had foreign matter it was reported by customer that an extrinsic particulate found and was identified to be a styrene acrylic copolymer with inclusions containing oxygen, silicon, sulfur, and barium.Rcc received a complaint via email.Sup#: sup-2025-0011, date initiated: 01apr2025, supplier: (b)(4), product#: 309680, sca part number: r15028, material details: syringe (sterile), 50 ml ll, bd tray *309680* (20/tray; 6 tray/cs), material lot number: 4246339, complaint details extrinsic particulate found and was identified to be a styrene acrylic copolymer with inclusions containing oxygen, silicon, sulfur, and barium.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the 1 particulate analysis report submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the report.Analysis of the report showed that the particle found has a very small dimension and during the packaging process the visual inspections are not performed with the aid of a microscope which would be needed to detect such a particle.No photos or sample where the particle was found were provided for evaluation.Additionally, the material was described as translucid soft material that is consistent with silicone material which is used to lubricate the stopper in the finished good.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD SYRINGE 50CC LL TIP CONVENIENCE PAK
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21868621
• Report Number: 9610847-2025-00108
• Device Sequence Number: 20807862
• Product Code: FMF
• UDI-Device Identifier: 00382903096800
• UDI-Public: (01)00382903096800(11)240924(17)290831(10)4246339
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 05/27/2025

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: Health Professional
• Device Catalogue Number: 309680
• Device Lot Number: 4246339
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown