MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS PLASTIPAK LUER-LOK; PISTON SYRINGE

Catalog Number	309658
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	08/04/2025
Type of Reportable Event	Serious Injury
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
The following information was provided by the initial reporter: it was reported that one subject treated with a syringe of this batch had an injection reaction (sae).Additional information provided: · could you confirm about the applied treatment: how was the reported site reaction at the injection site treated? · site reaction occurred between follow up visits of the patient approx.10 days after injection.This led to medical treatment at the emergency room and anti-inflammatory treatment with antibiotics.· could you confirm ¿a patient who was treated with a syringe from this batch had a serious adverse event (sae).The incident was a site reaction at the injection site¿.What is meant by ¿site reaction¿.Patient developed an iatrogenic subcutaneous abscess in the area of the injection site and local inflammation.· any medical intervention required as a result? emergency draining of the abscess and antibiotical treatment.Skin transplantation due to impaired wound healing necessary.Was anything unusual noted with the syringe? nothing unusual was noted with the syringe.
Additional Manufacturer Narrative
Investigation results: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.We will continue monitoring the complaint trend for the product and symptom.Batch 2012741 is considered in compliance with our product specification requirements.The complaint was not confirmed, and no capa evaluation was required per gpr-10033.This complaint type will continue to be trended within the post-market surveillance process, and any determined escalation will be managed there.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(6)- supplemental mdr - adverse event without identified device or use problem one sample and three photos of a 3 ml eurographic syringe (part number 309658) were received and evaluated.The photos show a loose syringe inside a clear bag with an orange sticker on the barrel and an unknown needle attached within the shield, captured from different angles.The physical sample, which was also loose and labeled with an orange sticker and an unknown yellow needle attached, was examined, and no defects were observed on the syringe.Based on the evaluation of both the sample and the photos, no defects were identified, and the observed condition is acceptable per product specifications.In addition, a device history record review was completed for the provided lot number 2012741.The review did not identify any rejected inspections or quality issues during production that could have contributed to the reported concern.Complaints received for this device and the reported condition will continue to be tracked and trended.Data will be captured in trend reports and monitored on a monthly basis, and the collected information is routinely reviewed by the business team to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: PLASTIPAK LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23815629
• Report Number: 1213809-2025-00783
• Device Sequence Number: 10098712
• Product Code: FMF
• UDI-Device Identifier: 00382903096589
• UDI-Public: (01)00382903096589(11)220112(17)261231(10)2012741
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 309658
• Device Lot Number: 2012741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 04/21/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 12/24/2025; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown