MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PLASTIPAK LUER-LOK; PISTON SYRINGE

Catalog Number	300865
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was provided by the initial reporter: it was reported that: i am emailing regarding a recent batch of 50ml syringes.Upon opening the syringes, we have identified an excess of what seems to be oil residue in the syringes.We use your syringes to manufacture sact, mab and civa treatments.When did the incident occur? before use.Short description: upon opening the syringes, identified an excess of what seems to be oil residue in the syringes.
Additional Manufacturer Narrative
G.4.Applicable 510k numbers are k182589;k980987.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: PLASTIPAK LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25310789
• Report Number: 3003152976-2026-00249
• Device Sequence Number: 21274104
• Product Code: FMF
• UDI-Device Identifier: 00382903008650
• UDI-Public: (01)00382903008650(11)251111(17)301031(10)2511043
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: Other
• Device Catalogue Number: 300865
• Device Lot Number: 2511043
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown