MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; SAFETYGLIDE NEEDLES

Catalog Number	305918
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	12/05/2023
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
It was reported that the bd safetyglide had rust/corrosion.The following information was provided by the initial reporter: "bd safetyglide needle 18gx1.5" had rust on shaft of needle.Lot # 3114521 exp: 03/31/2028." verbatim: rcc received a complaint via email.Email(s) attached.Event date: (b)(6) 2023.Event location: (b)(6).Event description: bd safetyglide needle 18gx1.5" had rust on shaft of needle.Lot # 3114521 exp: 03/31/2028.Harm to team member or patient? no.Product name: needle safety 18g x 1 1/2".Product ref: 305918.Lot number: 3114521.Bd customer account number: (b)(6).Further information provided by reporter: 1.Any sample or photo available for investigation? no if yes, are you able to provide the address of the facility for us to ship the return label? 2.What was the patient outcome? not able to provide.3.Was there a delay of, or change in, the course of treatment due to the event? slight delay.4.Did the issue happen during patient use? if yes, was there any injury? the needle was not used on the patient; no injury.5.Did the event directly, or indirectly involve a patient or user? indirectly; needle was intended for patient use but was not used on patient.
Additional Manufacturer Narrative
(b)(4) ¿ follow up mdr for device evaluation.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.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SAFETYGLIDE NEEDLES
• 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: 18461476
• Report Number: 1213809-2023-01519
• Device Sequence Number: 14225058
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: (01)30382903059189
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/22/2024

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: 305918
• Device Lot Number: 3114521
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/07/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown