MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 27X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305921
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Address was not located and il was used.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material: 305921 batch#: 4114203 it was reported that the bd needle sftygld 27x5/8 rb had foreign matter.The following information was provided by the initial reporter: verbatim: today, we were notified that one of our nursing units at hmc has detected contamination of an unidentified substance on bd 27g needles.Additional information provided: 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No known impact or harm to patient or healthcare professional.2.Can you please provide an exact date of event in format dd-mmm-yyyy? 08-20-2024 3.Total number of occurrences? two 27-gauge needles were found to have unknown substance / potential contamination inside.Both were sent to bd, per the attached, on 8-28-2024.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation/correction.Correction: following submission of initial mdr, the customer information was not correctly reported.Section e updated to reflect correct customer address.Evaluation: two samples and one photo were provided to our quality team for investigation.Through visual inspection, it was observed that both samples have loose green/gray color sticky-like texture foreign matter presented outside the fluid path.The potential root cause for the foreign matter defect is associated with the packaging 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 4114203.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 NEEDLE SFTYGLD 27X5/8 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 20186173
• Report Number: 1213809-2024-00615
• Device Sequence Number: 15232056
• Product Code: FMI
• UDI-Device Identifier: 30382903059219
• UDI-Public: (01)30382903059219(11)240423(17)290331(10)4114203
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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: 305921
• Device Lot Number: 4114203
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown