MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE STERILE; PISTON SYRINGE

Model Number 309626

Device Problems Physical Resistance/Sticking (4012); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

It was reported that during use with bd¿ luer slip tip syringe with attached needle 25 g x 5/8 in., sterile the needle pulled out of hub and the plunger was difficult to pull.The following information was provided by the initial reporter: vet said the following: using 1ml tb syringe slip tip 25gx 5/8 (309626) needles come off slip tip too easily.Also does not like how easy the plunger rod pulls back and they like a together pull for greater control.

Manufacturer Narrative

There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fmi.Common device name: hypodermic single lumen needle.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defects.H3 other text : see h10.

Event Description

It was reported that during use with bd¿ luer slip tip syringe with attached needle 25 g x 5/8 in., sterile the needle pulled out of hub and the plunger was difficult to pull.The following information was provided by the initial reporter: vet said the following: using 1ml tb syringe slip tip 25gx 5/8 (309626) needles come off slip tip too easily.Also does not like how easy the plunger rod pulls back and they like a together pull for greater control.

• Brand Name: BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE STERILE
• Type of Device: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16432486
• MDR Text Key: 310380929
• Report Number: 1213809-2023-00114
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: (01)30382903096269
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 309626
• Device Catalogue Number: 309626
• Device Lot Number: 2215904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1