MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309575
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
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 # 309575; batch # 4221164.It was reported that the bd luer-lok needle hub had a hold /crack / was damaged.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.My staff at our cleanroom informed me that they were having issues with a few of the bd plastipak 3 ml syringes.They said that looks like there¿s a hole in the hub and that when they were retrieving drug the drug was coming out from the hole in the hub.Lot # 4221164.I don¿t think it will be possible to see in the picture, but i do have at least one syringe with me if you want it to be inspected.Additional information provided: the exact date of events was on 09/27/2024.My tech only informed me of two times that this happened to her.The events happened with two medications: ondansetron and micafunging.No impact on patient.It only delayed a little time in the process of compounding.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation.One sample and one photo were provided to our quality team for investigation.The sample was assembled to a syringe with saline solution.It expelled solution through the needle tip and through the needle hub.The needle hub has a short shot located about 1/4" from the bottom of the needle hub.Based on the investigation and with the sample analysis the symptom reported is confirmed.Furthermore, a device history record review was completed for provided lot number 4221164.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD LUER-LOK
• 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: 20490227
• Report Number: 1213809-2024-00737
• Device Sequence Number: 11666415
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750(11)240808(17)290731(10)4221164
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 12/05/2024

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: 309575
• Device Lot Number: 4221164
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 10/20/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown