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

Catalog Number	305927
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.E.1.Address was not located and il was used.E.4.The initial reporter also notified the fda.Medwatch report is 3004122598-2024-00023.As no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, the complaint could not be confirmed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.
Event or Problem Description
It was reported that the bd safetyglide had a syringe needle connectivity issue.The following information was provided by the initial reporter: "the slip tip syringe and the needle were disconnecting while attempting to remove the needle from the patient." verbatim: rcc received a complaint via email.Email(s) attached.Medline complaint #: (b)(4) defect description: the slip tip syringe and the needle were disconnecting while attempting to remove the needle from the patient medline part #: 39765 product description: syr 1ml w/ndl 27gx5/8 safety vendor part #: 305927 lot #: unknown date reported: 12/02/2021 sample received: no response needed: summary of findings and corrective action complaint reported to fda as mdr-30 day.Reference no.(b)(4) additional information provided on 3/15/2024 1.Physical sample available or not available? not available 2.Any picture of this complaint? no 3.How was treatment completed for customer? unknown 4.How was the patient outcome? are there any clinical signs, health consequences or impact? no injury 5.Please provide batch number? unknown.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Follow up report for correction.Annex g code was incorrect in the initial mdr.Annex g code should be g04092 - needle.Annex b code was incorrect in the initial mdr.Annex b code should be b22 - insufficient information available.Annex c code was incorrect in the initial mdr.Annex c code should be c20 - no findings available.Annex d code was incorrect in the initial mdr.Annex d code should be d15 - cause not established.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: NEEDLE
• 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: 19014982
• Report Number: 1213809-2024-00192
• Device Sequence Number: 11711377
• Product Code: FMI
• UDI-Device Identifier: 30382903059271
• UDI-Public: (01)30382903059271
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2024

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: 305927
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown