MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK; PISTON SYRINGE

Catalog Number	300613
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 20ml e/t had foreign matter.The following information was provided by the initial reporter: ref: (b)(4).Lot number: 2507059 date of occurrence: 23/03/2026 description of facts: it was reported that syringe still sealed but found contaminated from inside with clear traces of contamination / staining contamination (see photos).Clinical consequences observed: none: syringe isolated and quarantined for investigation.The flanges are marked ¿s30¿ and ¿44¿.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD PLASTIPAK
• 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: 24760474
• Report Number: 3003152976-2026-00164
• Device Sequence Number: 13053580
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: (01)00382903006137(11)250717(17)300630(10)2507059
• Combination Product (Y/N): N
• Initial Reporter Country: MN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: 300613
• Device Lot Number: 2507059
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown