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

Catalog Number	309570
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305917, batch#: 3282425.It was reported that the bd safetyglide needle was clogged/blocked.The following information was provided by the initial reporter: "the plunger was either stuck on the syringe or the needle she was using was "clogged" causing her not to be able to push down on the plunger." verbatim: rcc received a complaint via email.Email(s) attached.Item: 305917, quantity affected:1 box, serial/lot number:(b)(6).Po : (b)(6).Are any samples available for return? yes.Additional information provided: 1.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? this did occur in patient use.Patient had needle administered twice to deltoid muscle.2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No.3.Can you please provide an exact date of event in format dd-mmm-yyyy? 23-05-2024.
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
Pr 10319396 follow up report for correction.Catalog number was incorrect in the initial mdr.As per manufacturing plant, correct catalog number for product is 309570.
Event or Problem Description
As per manufacturing plant, correct catalog number for product is 309570.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Investigation results: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.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 of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD 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: 19570970
• Report Number: 1213809-2024-00395
• Device Sequence Number: 8566830
• Product Code: FMF
• UDI-Device Identifier: 30382903095705
• UDI-Public: (01)30382903095705(11)231009(17)280930(10)3282425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 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: Health Professional
• Device Catalogue Number: 309570
• Device Lot Number: 3282425
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: Not provided; 12/06/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 12/02/2024; 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown