MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number	309623
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Materials#: (b)(4).Batch#: (b)(4).It was reported that the bd syringe 1ml s/t w/ndl 27x1/2 rb needle was clogged / blocked.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Customer have been injecting her husband with a medication each week for over 10 years.Within the last two months we have had issues with bd needles and the tips exploding off during injection, while medication is being pushed.This explosion has led me to be exposed to his medication twice.We are using bd 1 ml tb syringe.Lot number 3181198.We have wasted two doses and need to pay out of pocket to have these doses provided again.Please advise what additional information you need to remedy this situation and if my out-of-pocket medication costs can be reimbursed.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.E.1.Address was not located and il was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle clogged/blocked.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.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 27X1/2 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: 20348911
• Report Number: 1213809-2024-00686
• Device Sequence Number: 8053704
• Product Code: FMF
• UDI-Device Identifier: 30382903096238
• UDI-Public: (01)30382903096238(11)230630(17)280531(10)3181198
• 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: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: Lay User/Patient
• Device Catalogue Number: 309623
• Device Lot Number: 3181198
• 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: 11/07/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown