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	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the bd safetyglide needle was clogged/blocked.The following information was provided by the initial reporter: "we use the mckesson 25gx1" safety hypodermic needles (#306616).We've been having some issues with these; when injecting the medication, it's as though the needle becomes blocked.Sometimes we inject 0.2ml before it blocks up, sometimes it's 0.5ml, that part is random.But when this happens, we have to poke the patient a second time.Any recommendation? have you heard about this from anyone else? i know this is the 2nd or 3rd box that we've had this issue with, so i'm not sure where to go from here." additional information received on 01/17/24: 1) mckesson safety hypodermic needles glide, thin wall 25g x 1 in mfr# 306616, lot 3255801 *there was a previous box also, but we worked our way through that one, so i do not have the lot from that box.2) i do not have an exact date of when this occurred.It's been happening over the last month, except it did happen to dr.(b)(6) yesterday, (b)(6) 2024.3) we do not have a "physical sample" available.Due to this being a needle, it's disposed into a biohazard container.If we need to keep a needle, you will need to inform me of this.4) this absolutely involves the patient and the user.As stated, this happened to dr.(b)(6) just yesterday.When this happens, we begin to inject the medication into the patient and it's as though the needle clogs, then we have to discard the needle and replace it with a new one, then poke the patient again to finish giving the medication.Not only is this embarrassing on our part, but we have to poke the patient twice.In one instance, the nurse had 2 faulty needles in a row and had to poke the patient 3 times!.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr 9526154 ¿ 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 (3255801) 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.H3 other text : see h10 manufacture narrative.
Additional Manufacturer Narrative
(b)(4) follow up mdr #2 for device evaluation with samples.Following the submission of the initial follow for device evaluation, samples were received.(b)(4) samples were received.They came in sealed packaging blisters.Lot number 3255803 had (b)(4) samples and lot number 3255801 had (b)(4) samples.(b)(4) random samples were selected per procedure.Visual inspection was performed.No defects or imperfections were observed.Each sample was connected to a syringe with saline solution.All the sample expelled the solution with normal flow.Based on the investigation and with the sample analysis the defect reported by the customer could not be confirmed.A probable root cause could not be determined.A device history record review was completed for provided lot numbers 3255801 and 3255803 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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
No additional information.

• 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: 18628412
• Report Number: 1213809-2024-00054
• Device Sequence Number: 7954944
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 04/03/2024

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: 3255801
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 02/23/2024; 04/03/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/23/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown