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

Catalog Number	305903
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305903.Lot # 2258762.It was reported that the bd safetyglide needle was clogged/blocked.The following information was provided by the initial reporter: "the needle came off after insertion when trying to push medication." sku: 305903.Lot - 2258762.Additional information provided: my son administers the injection himself so there was no injury to patient or healthcare professional.The adverse event was the waste of medication that happened after the needled came off.There is only a limited supply of meds so any waste can affect the treatment.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: one photo was provided to our quality team for evaluation.The photo shows a packaging blister top web.No other information could be obtained from the photo and no defects could be observed; therefore, the incident could not be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Since no defect could be observed from the photo and no physical sample was sent for review, a root cause could not be established.
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: 19506071
• Report Number: 1213809-2024-00363
• Device Sequence Number: 7452074
• Product Code: FMI
• UDI-Device Identifier: 30382903059035
• UDI-Public: (01)30382903059035(11)220915(17)270831(10)2258762
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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: Lay User/Patient
• Device Catalogue Number: 305903
• Device Lot Number: 2258762
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 12/06/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown