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

Model Number	305787
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe), pma / 510(k)#: k161170 (needle).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.
Event or Problem Description
It was reported that the bd eclipse¿ safety thin wall needle separated from the bd luer-lok¿ syringe and broke.The following information was provided by the initial reporter: "break a0413 - material separation a0501 - detachment of device or device component".
Additional Manufacturer Narrative
H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.Batch number is unavailable and hence unable to perform the dhr review.
Event or Problem Description
It was reported that the bd eclipse¿ safety thin wall needle separated from the bd luer-lok¿ syringe and broke.The following information was provided by the initial reporter: "break a0413 - material separation a0501 - detachment of device or device component".
Additional Manufacturer Narrative
H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that the bd eclipse¿ safety thin wall needle separated from the bd luer-lok¿ syringe and broke.The following information was provided by the initial reporter: "break a0413 - material separation a0501 - detachment of device or device component".
Event or Problem Description
It was reported that the bd eclipse¿ safety thin wall needle separated from the bd luer-lok¿ syringe and broke.The following information was provided by the initial reporter: "break a0413 - material separation a0501 - detachment of device or device component".
Additional Manufacturer Narrative
The following information has been updated: d.4 medical device lot #: 9203918.D.4 medical device expiration date: 2024-07-31.H.4 device manufacture date: 2019-07-22 h3 other text : see h10.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12328839
• Report Number: 8041187-2021-00731
• Device Sequence Number: 20005292
• Product Code: FMI
• UDI-Device Identifier: 30382903057871
• UDI-Public: 30382903057871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 10/25/2022

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: Other
• Device Expiration Date: 07/31/2024
• Device Model Number: 305787
• Device Catalogue Number: 305787
• Device Lot Number: 9203918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 08/31/2021; 10/25/2022
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/10/2021; 10/01/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• 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