MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD 25G 1IN ECLIPSE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305761

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 07/03/2023

Event Type  malfunction  

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 Description

It was reported that during vaccination with bd 25g 1in eclipse needle the seal to the hub was loose and medication leaked.The following information was provided by the initial reporter: i had an ma who was in the middle of giving a shingrix vaccine today who reports that the vaccine escaped from the base of the needle.She reports the needle did not seem to seal to the hub of the vaccine vial.Unfortunately, we lost the full dose of shingrix.She discarded the needle due to the fact it had penetrated the patients' arm.She brought me an identical needle to the one she had used : bd eclipse 25g x 1 lot# 1204246 exp: 07/31/2026.

Manufacturer Narrative

H.6.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 numbers 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.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that during vaccination with bd 25g 1in eclipse needle the seal to the hub was loose and medication leaked.The following information was provided by the initial reporter: i had an ma who was in the middle of giving a shingrix vaccine today who reports that the vaccine escaped from the base of the needle.She reports the needle did not seem to seal to the hub of the vaccine vial.Unfortunately, we lost the full dose of shingrix.She discarded the needle due to the fact it had penetrated the patients' arm.She brought me an identical needle to the one she had used : bd eclipse 25g x 1 lot# 1204246 exp: 07/31/2026.

• Brand Name: BD 25G 1IN ECLIPSE NEEDLE
• Type of Device: 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17397397
• MDR Text Key: 320604294
• Report Number: 8041187-2023-00364
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903057610
• UDI-Public: 00382903057610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305761
• Device Lot Number: 1204246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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