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

Catalog Number	306616
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
99 samples were provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed.50 samples were randomly selected and were then connected to a syringe with saline solution.All samples expelled the solution with normal flow, clogged needle was not confirmed.Furthermore, a device history record review was completed for provided batch number 3300424.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.During review of the process, process variations during the needle lubricant application can create clogged needles.Corrective and preventative actions have been implemented.Several quality initiatives have been implemented on our manufacturing line to ensure that the needle lubricant application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.Based on the investigation and with the sample analysis the symptom reported was not confirmed.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.
Event or Problem Description
Material# 306616 batch# 3300424.It was reported by customer that the needle plugs halfway through giving an injection verbatim rcc received a complaint via email.Email(s) attached.Complaint number dm-24-0535.Report date 5/24/24.Factory/manufacturer.Bd.Mfr reorder #.192-n251s.Product name.Needle, sfty 192-n251s preventsg org 25gx1".Lot / serial number.(b)(6).Product concern.The needle plugs half way through giving an injection.
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# 306616.Batch# 3300424.It was reported that the bd safetyglide needle clogged/blocked.The following information was provided by the initial reporter: "the needle plugs halfway through giving an injection." verbatim: rcc received a complaint via email.Complaint number (b)(4).Report date 5/24/24.Factory/manufacturer bd.Mfr reorder # (b)(4).Product name needle, sfty 192-n251s preventsg org 25gx1" lot / serial number (b)(6).Product concern: the needle plugs half way through giving an injection.Additional information provided 1.What is the date of event? (b)(6) 2024.2.Please share the material number.Lot number 3300424.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No harm but the needle became plugged halfway through giving any injection so the needle had to be changed and patient then had to be repoked to finish administering the injection.4.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? needles were returned to our ames purchasing dept.

• 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: 19495360
• Report Number: 1213809-2024-00357
• Device Sequence Number: 15606396
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/13/2024

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: 306616
• Device Lot Number: 3300424
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/09/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown