MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 25X5/8 RB; PISTON SYRINGE

Catalog Number	309570
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
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# 309570.Batch# 3303211.It was reported that the bd syringe 3ml ll w/ndl 25x5/8 rb had a scale marking issue.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Date: 09/06/2024.Complaint number: (b)(4).Account name: rmg west.Contact person: (b)(6).Item description: syr, ll,3ml,25gx 5/8", needle combo.Incident description: missing measurements.Hello, we have received a quality complaint on product sold to our customer.Please contact the customer and cc distributedquality@medline.Com and djreyes@medline.Com on any future communication.Injuries or adverse event: no.Item: 309570.Quantity affected: 2 bx.Serial/lot number: 3303211.Po: (b)(4).Are any samples available for return? yes.Reported issue: a few of the syringes were missing part of the measurements on the syringe.For instance, the lines are missing from 0.1 ml to 1.4 ml.Item b-d309570 with lot # is 3303211.Expiration 9/30/2028.I have 3 examples at my desk if someone needs to see what i am referring to.Customer disposition request: repair.Additional information provided: are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.I was first notified on 09/04/2024 but it is unknown as to when we obtained the supply.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No harm.Product was identified prior to use and all affected supply removed from patient care.Please wait for three business days and let us know once you received the shipping label and the sample has been shipped from your end? shipping label not received yet.I will notify you once i get it.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation.(b)(4) samples were provided to our quality team for investigation.Through visual inspection, it was observed that all samples have missing all the scale markings from the zero line down to the 1-1/2ml graduation line.The condition observed is non-conforming per product specification.Potential root cause for the scale markings missing defect is associated with the marking process.These conditions are occurring below their expected frequency so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 3303211.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 3ML LL W/NDL 25X5/8 RB
• 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: 20288231
• Report Number: 1213809-2024-00652
• Device Sequence Number: 20854594
• Product Code: FMF
• UDI-Device Identifier: 30382903095705
• UDI-Public: (01)30382903095705(11)231030(17)280930(10)3303211
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/25/2024

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: Other
• Device Catalogue Number: 309570
• Device Lot Number: 3303211
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown