MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305787
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle of the bd luer-lok¿ syringe with the bd eclipse¿ safety thin wall needle dislodged from the insertion site after the user hit the mechanism.The following information was provided by the initial reporter: "writer was using the 3ml syringe with the pink safety mechanism to cover the needle after deployment.The writer hit the mechanism after inserting the needle and the needle was dislodged from the site.No vaccine was administered.It is felt this happened due to the design of the needle / safety device.The pink mechanism that is used to cover the needle once the vaccine is given, sticks out from the syringe close to the hub.It is awkward to change the position of the hand to inject the vaccine as that mechanism is in the way.Immunizing an adult that does not move is easier as you can take the time to adjust your hand, but with a moving child, it is much more difficult.Many of the staff do not feel comfortable with this syringe/needle combo and don¿t use it.They will use the 3 ml syringe and attach a 1 inch needle to it that does not have this type of mechanism.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of needle defect ¿ other was not confirmed upon inspection of the photos.The supplied photos did not show enough evidence to confirm the reported defect.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Batch number is unavailable and hence unable to perform the dhr review.H3 other text : see h10.
Event or Problem Description
It was reported that the needle of the bd luer-lok¿ syringe with the bd eclipse¿ safety thin wall needle dislodged from the insertion site after the user hit the mechanism.The following information was provided by the initial reporter: "writer was using the 3ml syringe with the pink safety mechanism to cover the needle after deployment.The writer hit the mechanism after inserting the needle and the needle was dislodged from the site.No vaccine was administered.It is felt this happened due to the design of the needle / safety device.The pink mechanism that is used to cover the needle once the vaccine is given, sticks out from the syringe close to the hub.It is awkward to change the position of the hand to inject the vaccine as that mechanism is in the way.Immunizing an adult that does not move is easier as you can take the time to adjust your hand, but with a moving child, it is much more difficult.Many of the staff do not feel comfortable with this syringe/needle combo and don¿t use it.They will use the 3 ml syringe and attach a 1 inch needle to it that does not have this type of mechanism.".

• Brand Name: BD LUER-LOK¿ SYRINGE WITH THE BD ECLIPSE¿ SAFETY THIN WALL 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15965902
• Report Number: 8041187-2022-00726
• Device Sequence Number: 14870009
• Product Code: FMI
• UDI-Device Identifier: 50382903057875
• UDI-Public: 00382903057870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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: 305787
• Device Lot Number: UNKNOWN
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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