MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 needle sftygld 21x1-1/2 rb tw needle pulled out of the hub.The following information was provided by the initial reporter: one complaint has been reported for the defect 'needle detached from the socket during injection' (see photos).The defect was observed during use.The patient was given the product, but when the syringe was withdrawn, the needle became stuck in the skin.The cannula came loose from its holder.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle pulled out of hub it was reported the needle detached from the socket during injection.To aid in the investigation, one sample with no blister package and four photographs were received for evaluation by our quality team.A visual inspection was performed; the needle was loose from the needle hub and epoxy was present on 40% of the needle outer diameter.The four photographs provided show a needle assembly attached to a syringe, including the plastic shield, a side view of the needle, a top view of the needle hub, and a close-up of the needle.This condition could occur if there was an insufficient epoxy application, potentially due to a jam at the cannulator that was not detected during subsequent processing.However, this product shelf life has expired.Bd does not make claims of the efficacy of expired product.Complaints received for this device and the reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly.Our business team regularly reviews collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle pulled out of hub.Four photos were provided showing a syringe with the needle assembly, including the plastic shield, a side view of the needle, a top view of the needle hub, and a close up of the needle.The needle appears to have an epoxy droplet that does not provide full 360 degree coverage around its outer diameter.Based on the investigation and photo analysis, the reported issue is confirmed.The most likely root cause is insufficient epoxy application, as indicated by the images.It is also possible that a jam occurred at the cannulator, resulting in inadequate epoxy coverage and remaining undetected through subsequent processes.Verification of the cannulator showed that its settings were correct and product flow was good.A device history record review was completed for material number 305917, lot 3324374.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and is in compliance with applicable product specifications.Complaints received for this device and the reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly.Our business team regularly reviews collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the needle detached from the socket during injection.To aid in the investigation, one sample with no blister package and four photographs were received for evaluation by our quality team.A visual inspection was performed, the needle was loose from the needle hub and epoxy was present on 40 percent of the needles outer diameter.The four photographs provided show a needle assembly attached to a syringe, including the plastic shield, a side view of the needle, a top view of the needle hub, and a close up of the needle.This condition could occur if there was an insufficient epoxy application, potentially due to a jam at the cannulator that was not detected during subsequent processing.However, this product shelf life has expired.Bd does not make claims of the efficacy of expired product.
Additional Manufacturer Narrative
(b)(4).- supplemental mdr - needle pulled out of hub correction: following submission of initial mdr, customer provided correct lot.Section d updated to correct lot.Evaluation: it was reported the needle detached from the socket during injection.To aid in the investigation, one sample with no blister package and four photographs were received for evaluation by our quality team.A visual inspection was performed; the needle was loose from the needle hub and epoxy was present on 40% of the needle outer diameter.The four photographs provided show a needle assembly attached to a syringe, including the plastic shield, a side view of the needle, a top view of the needle hub, and a close-up of the needle.This condition could occur if there was an insufficient epoxy application, potentially due to a jam at the cannulator that was not detected during subsequent processing.Verification of the cannulator was performed.The settings were correct, and product flow was good.Furthermore, a device history record review was completed for provided lot number 3324374.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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 was provided.

• Brand Name: SAFETYGLIDE
• 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: 24205993
• Report Number: 1213809-2026-00037
• Device Sequence Number: 9672263
• Product Code: FMI
• UDI-Device Identifier: 00382903059171
• UDI-Public: (01)00382903059171
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/16/2026

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: 305917
• Device Lot Number: 3324374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/14/2026; 03/03/2026; 04/03/2026; 04/16/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 02/19/2026; 03/23/2026; 04/06/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown