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

Catalog Number	309695
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material# (b)(4), batch# 4234195.It was reported that the bd luer-lok package seal integrity was poor / questionable.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.There were also 4 samples of lot 4234195 received and retained in vh.These samples had the same issue."not fully sealed around the edges" the pr was created based on the additional sample received.
Additional Manufacturer Narrative
(b)(4).Package seal integrity poor / questionable.Four samples of 10ml control syringes from batch 4234195 were received and evaluated.All the samples were observed to have an open side seal with grid ranging from 2" to 3".All the packages also had crinkling of the package, in conjunction with the open seal with grid is consistent with the package seal being forced open after being sealed.The condition observed is non-conforming per product specification.Potential root cause for the open seal with grid defect is associated with the packaging process.As part of this investigation the technical logs, production database, and production records were reviewed.During this batch there was an issue with robot pick-up placement and robots crashing into boxes which most likely attributed the side seal being forced open once they were sealed.As corrective actions, quality alert will be issued to the plant and all associates who ran the order will be re-educated to the applicable work instruction.
Event or Problem Description
No additional information was provided.

• Brand Name: BD 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: 21158718
• Report Number: 1213809-2025-00005
• Device Sequence Number: 7656424
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955(11)240821(17)290731(10)4234195
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 03/06/2025

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: 309695
• Device Lot Number: 4234195
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown