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	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #:309695 batch#:4214856.It was reported that the bd luer-lok package seal integrity was poor / questionable.The following information was provided by the initial reporter: customer reports concerns with seal.Ref 209695 lot 4214856 "weve been consistently getting defective bd 10ml control syringes ref 209695 with the lot 4214856.Weve probably had 6-7 now that are not fully sealed around the edges.I think this needs to get escalated to bd to recall this lot.Let me know what other info you need." "i have 4 more of these with the same lot #." additional information provided: 1.Please provide the date of event.11.12.24 & 11.25.24 2.Please provide the address of the facility for us to ship the return label? (b)(4), attn: (b)(6).3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.None noted.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(6) - supplemental mdr - package seal integrity poor / questionable since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Previous investigation has revealed that 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 were problems with robot pick-up placement most which likely attributed the side seal being forced open once they were sealed.As corrective actions, quality alert will be issued to the plant, all associates involved will be re-educated to the applicable work instruction and communicated to all technical resources to document adjustments on the production records following repairs.
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: 20996941
• Report Number: 1213809-2024-00984
• Device Sequence Number: 9896083
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955(11)240801(17)290731(10)4214856
• 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): 01/24/2025

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: Health Professional
• Device Catalogue Number: 309695
• Device Lot Number: 4214856
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 12/21/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown