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	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Other lot number includes 4179466 and other expiration date includes 2029-05-31.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.H.4.Other lot number device manufacture date is 2024-06-27.
Event or Problem Description
Material # 309695, batch # 4179466, 4164479.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: rcc received a complaint via email.Email(s) attached the seal around the edge of the sterile packaging is failing, causing sterility issues in procedure rooms/operating rooms.Event date: 9-11-2024, product name: itm-1150085 - syringe 10ml control, product ref: (b)(4), lot numbers: 4179466 and 4164479, bd customer account number: (b)(6), lot 4179466: (b)(4) eaches, lot 4164479: (b)(4) eaches.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: eleven samples from batch 4179466 and two samples from batch 4164479 were provided to our quality team for investigation.Nine samples from batch 4179466 observed to have an open side seal with grid ranging from 2" to 4", and both packages from batch 4164479 having the side seal open with grid greater than 2".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.Quality alert will be issued to the plant, and re-training will be provided to responsible associate to address these issues.Additionally, communication to all technical resources to document adjustments on the production records following repairs.Furthermore, a device history record review was completed for provided lot number 4179466 and 4164479.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• 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: 20320842
• Report Number: 1213809-2024-00670
• Device Sequence Number: 8147128
• Product Code: FMF
• UDI-Device Identifier: 30382903096955
• UDI-Public: (01)30382903096955(11)240612(17)290531(10)4164479
• 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): 10/11/2024

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: 4164479
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/21/2024
• 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
• Patient Sex: Unknown