MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305760
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with an unspecified amount of bd eclipse¿ needle the needle was blocked.Patient has to be injected several times as needle is replaced.The following information was provided by the initial reporter, translated from french to english: the department reports that after several injections of vidaza (azacitidine), the subcutaneously injected product regularly fails to inject, and that even increasing the injection pressure or aspirating the product does not change anything.The patient must therefore be injected several times with the same syringe, but with a different needle.Even with this change, the product still has trouble getting through.The department points out that staff respect the procedures for injecting the product and storing it in the department (room temperature 30 minutes before injection, etc.), and that in the past they used other 25 g needles, and this did not happen.The material was not kept.
Additional 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 or Problem Description
It was reported that during use with an unspecified amount of bd eclipse¿ needle the needle was blocked.Patient has to be injected several times as needle is replaced.The following information was provided by the initial reporter, translated from french to english: the department reports that after several injections of vidaza (azacitidine), the subcutaneously injected product regularly fails to inject, and that even increasing the injection pressure or aspirating the product does not change anything.The patient must therefore be injected several times with the same syringe, but with a different needle.Even with this change, the product still has trouble getting through.The department points out that staff respect the procedures for injecting the product and storing it in the department (room temperature 30 minutes before injection, etc.), and that in the past they used other 25 g needles, and this did not happen.The material was not kept.
Additional Manufacturer Narrative
H.6.Investigation summary: a device history record review was completed for provided material number 305760 and lot number 2301004.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, twenty (20) retained samples of the same lot number were obtained from the manufacturing facility for review.The retained samples were assembled with a bd discardit 2ml syringe and liquid was found to move normally through the cannula with no signs of clogging.Inspections for occluded cannula condition are performed as part of the routine in-process inspections after assembly.In certain circumstances, the drug used can become deposited within the cannula, causing the needle to block due to crystallization.Occlusion is most likely to occur if the drug remains in the needle for an extended period of time.If this issue were to reoccur, we would greatly appreciate the opportunity to review the affected sample.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17276144
• Report Number: 3002682307-2023-00184
• Device Sequence Number: 20153732
• Product Code: FMI
• UDI-Device Identifier: 00382903057603
• UDI-Public: 00382903057603
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100209
• 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): 08/10/2023

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 Catalogue Number: 305760
• Device Lot Number: 2301004
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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