MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE CONTROL 10ML LL; 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	10/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 309695.Batch # 4214856.It was reported that the bd syringe control 10ml ll package seal integrity was poor / questionable.The following information was provided by the initial reporter: verbatim: customer verbatim: please open a quality complaint for this bd product at (b)(6).Here are the relevant event and product details: event date: 10-23-2024.Event description: ¿sterile control syringe packaging is opening prematurely on the sides of the packaging.¿ harm to team member or patient? no harm to patient or team member.Product name: itm-1150085 - syringe 10ml control.Product ref: 309695.Lot number: 4214856.Bd customer account number: (b)(4).Qty reported with this issue: (b)(4) at this time.Photo of actual product is attached.
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
Six photos were provided to our quality team for investigation.Three photos show the top web graphics side of the top web with wrinkling and applicable product information including the variable data.The next three photos show each one package having open side seal with grid greater than 2".The wrinkling 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 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.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE CONTROL 10ML LL
• 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: 20727373
• Report Number: 1213809-2024-00854
• Device Sequence Number: 8989429
• 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): 01/14/2025

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: 10/24/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/16/2025
• 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