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

Model Number	305786
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: g.5.Pma / 510(k)#: k980987 (syringe).G.5.Pma / 510(k)#: k161170 (needle).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 the bd luer-lok syringe with bd eclipse safety needle was damaged.The following information was provided by the initial reporter: there is a breakage in the syringe.
Event or Problem Description
It was reported that the bd luer-lok syringe with bd eclipse safety needle was damaged.The following information was provided by the initial reporter: there is a breakage in the syringe.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 22-may-2023.H6: investigation summary: our quality engineer inspected the 3 photos and 1 used sample submitted for evaluation.The reported issue of barrel cracked was confirmed upon inspection of the sample and photos.Analysis of the sample and photos showed that there was damage to the syringe.The damages were observed to be on the barrel of the syringe on the scale mark in between 1 and 2 inches.Bd determined that the cause of the failure was associated to our manufacturing process.A portion of our manufacturing line was identified to have the ability to cause the damages observed.Defective and damaged products are supposed to be manually removed by production technicians upon visual inspection prior to the packaging process.Actions have been made to prevent the recurrence of this defect.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD LUER-LOK SYRINGE WITH BD ECLIPSE SAFETY 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17050349
• Report Number: 8041187-2023-00242
• Device Sequence Number: 3491251
• Product Code: FMI
• UDI-Device Identifier: 30382903057864
• UDI-Public: (01)30382903057864
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: SEE H.10
• 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): 06/19/2023

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2026
• Device Model Number: 305786
• Device Catalogue Number: 305786
• Device Lot Number: 1175937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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