MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 3ML LL TIP BULK CONVENIENCE PAK

Catalog Number	309702
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that observed a particle inside a 3ml syringe during visual inspection.Complaint via email.We would like to file a product complaint for a particle in a 3ml syringe.Date of the event: 03/05/2026.How many items were affected per lot? 1.Is the product available to be returned for investigation? no, syringe saved for internal product visual inspection library.How many items are available to return? 0.Our integradose reference number is: (b)(4).On 03/05/2026, during production using the 3ml syringes, pn: 309702, technicians observed a particle inside a 3ml syringe during visual inspection.The majority of syringes used were from lot#: 5339733; however, since units from other lots were used, it is not possible to specify a single lot.This article is similar to those we've been seeing at integradose.Additional information received on 9-mar-2026: no patient harm, injury or complication occurred as a result of this event.However, integradose had to dispose of a full syringe of product as the particle was identified through our visual inspection process after the filling of the syringe.
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
Investigation results: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the photo.Analysis of the sample showed that a white colored particle can be observed, it cannot be determined from the photo if it is on the barrel surface, embedded within the plastic or inside the barrel of the syringe.Bd cannot confirm the cause of the failure since no sample was returned for evaluation.Examination of the actual product involved may provide clarification as to the cause of the reported failure.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: SYRINGE 3ML LL TIP BULK 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: 24663550
• Report Number: 9610847-2026-00128
• Device Sequence Number: 5054918
• Product Code: FMF
• UDI-Device Identifier: 30382903097020
• UDI-Public: (01)30382903097020(17)300930(10)5339733
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: 309702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown