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

Catalog Number	305917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
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 needle hub had a hole was cracked/damaged.The following information was provided by the initial reporter translated from chinese to english: "continuously received feedback from hospitals, after opening and loading the needle, to inject, when injecting, it started leaking, there is a video, then received the physical view, there is a piece missing from the tip of the needle at the green, the missing part is inside the luer head, the tip of the needle at the green ruptured off a piece, which caused the leakage.".
Event or Problem Description
Continuously received feedback from hospitals, after opening and loading the needle, to inject, when injecting, it started leaking, there is a video, then received the physical view, there is a piece missing from the tip of the needle at the green, the missing part is inside the luer head, the tip of the needle at the green ruptured off a piece, which caused the leakage.
Additional Manufacturer Narrative
One sample was received.It came with no packaging blister.Visual inspection was performed with 10x magnification.The safety mechanism has been activated.The bottom part of the needle hub is damaged.No other defect or imperfection was observed.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.Probable root cause is that a jam occurred in the assembly process inducing the symptom reported and not detected in the next processes.Verification of the assembly process was performed.Alignment of feeders and fixtures were correct, and the flow of products was good.A device history record review was completed for provided batch number 2292621 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• 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: 19072013
• Report Number: 1213809-2024-00207
• Device Sequence Number: 6994661
• Product Code: FMI
• UDI-Device Identifier: 30382903059172
• UDI-Public: (01)30382903059172
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 305917
• Device Lot Number: 2292621
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown