MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿HYPODERMIC NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	300253
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd hypoint¿hypodermic needle the needle was clogged.The following information was provided by the initial reporter: patient advised that she injected yesterday and the injection didn¿t work.She had 3, so used anther which worked.No further information provided.Additional details received: description of event: pt mum advised that when she tried using the fizayr the injection she found the injection did not go in and had left marks and pricked the skin and advised none of the liquid went in device details: fizayr has the device been dropped? no was the device inspected before use & in date? yes was the indicator window observed colour fill quantity observed? yes how long was the pen left out of the fridge prior to administration? no did you pinch the skin (if required)? yes how was the device cap removed? (twisted or pulled?) pulled where did you inject? do you rotate the injection site regularly? stomach are you able to hold the injection at a 90-degree angle? yes how long was the device held for at the injection site? no did the patient hear a click? how many? no did the inspection window change colour before the device was removed from the skin? no did the needle pierce the skin? (if yes ae has occurred).Yes was any liquid present at the injection site? no has the patient used another device? yes number of devices left? 4 outcome: decision: faulty pens missed dose: no missed dose sample available: no in the sharps bin batch number: tfvg07a01 exp date: 06/2024 replacement quantity: no replacements advice given (if any): pt mum advised that a new delivery has been sent out to them and we will amend her call dates accordingly.
Additional Manufacturer Narrative
H.6.Investigation summary: unconfirmed: no evidence provided h3 other text : see h.10.
Event or Problem Description
It was reported that bd hypoint¿hypodermic needle the needle was clogged.The following information was provided by the initial reporter: patient advised that she injected yesterday and the injection didn¿t work.She had 3, so used anther which worked.No further information provided.Additional details received: description of event: pt mum advised that when she tried using the fizayr the injection she found the injection did not go in and had left marks and pricked the skin and advised none of the liquid went in device details: fizayr has the device been dropped? no was the device inspected before use & in date? yes was the indicator window observed colour fill quantity observed? yes how long was the pen left out of the fridge prior to administration? no did you pinch the skin (if required)? yes how was the device cap removed? (twisted or pulled?) pulled where did you inject? do you rotate the injection site regularly? stomach are you able to hold the injection at a 90-degree angle? yes how long was the device held for at the injection site? no did the patient hear a click? how many? no did the inspection window change colour before the device was removed from the skin? no did the needle pierce the skin? (if yes ae has occurred).Yes was any liquid present at the injection site? no has the patient used another device? yes number of devices left? 4 outcome: decision: faulty pens missed dose: no missed dose sample available: no in the sharps bin batch number: (b)(4) exp date: (b)(6) 2024 replacement quantity: no replacements advice given (if any): pt mum advised that a new delivery has been sent out to them and we will amend her call dates accordingly.

• Brand Name: BD HYPOINT¿HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 19116379
• Report Number: 8041187-2024-00035
• Device Sequence Number: 7216378
• Product Code: FMI
• UDI-Device Identifier: 00382903002535
• UDI-Public: 00382903002535
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: 300253
• Device Lot Number: 0106994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown