MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL W/NDL 21X1 RB; PISTON SYRINGE

Catalog Number	309632
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - scale marking issue.Two photos were provided to our quality team for investigation.One photo show two loose syringe with one large ink dot on each of the barrels, and the other photo shows one packaged syringe with one large ink dot on the barrel.The condition observed is non-conforming per product specification.Potential root cause for the scale marking defect is associated with the marking process.These defects are occurring below an expected rate, so no corrective action is required at this time.Furthermore, a device history record review was completed for provided lot number 3324994.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.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material: 309632.Batch#: 3324994.It was reported that the bd syringe 5ml ll w/ndl 21x1 rb had a scale marking issue.The following information was provided by the initial reporter: it was reported by the customer that 3 syringes from this lot have black mark that goes all around the syringe.Appears to be on the outside of the syringes.Verbatim: rcc received a complaint via email.Email(s) attached.3 syringes from this lot have black mark that goes all around the syringe.Appears to be on the outside of the syringes.Product#: 309632, lot#: 3324994.Customer response: 1.Date of event: 09/10/2024.2.The site no longer has the 5ml syringes.3.No adverse events of serious injury reported to patient of healthcare professionals.

• Brand Name: BD SYRINGE 5ML LL W/NDL 21X1 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: 20511276
• Report Number: 1213809-2024-00750
• Device Sequence Number: 8524813
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: (01)30382903096320(11)231120(17)281031(10)3324994
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/14/2024

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: 309632
• Device Lot Number: 3324994
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 11/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown