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

Catalog Number	309570
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
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 3ml ll w/ndl 25x5/8 rb needle hub had a hole or was cracked/damaged.Complaint via email.X has received syringes where the attached needle/cover is either broken or damaged.We have found this on only 1 lot of parts.See tab labeled pictures of damage.One picture show the plastic holding the needle is actually broken at the base where it turns into the syringe, one picture show the plastic holding the needle is actually broken at the base where it turns into the syringe, and the rest of the blue plastic with the needle still in the cover the other shows damage to the needle cover, like the needles/covers are turned onto the syringes by a machine and it was gripping too tight causing damage or actually breaking them.(b)(4).Additional information: attached are pictures of the sample parts found.We have the parts on hold but may have to sort through because shipments from cardinal health are being delayed again.We are not at the moment having production issues due to lack of product, but last year we had significant issues and don't want to be in the same boat again.

• 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: 25150837
• Report Number: 1213809-2026-00249
• Device Sequence Number: 9397160
• Product Code: FMF
• UDI-Device Identifier: 00382903095704
• UDI-Public: (01)00382903095704(10)5258256
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• 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: 309570
• Device Lot Number: 5258256
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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