MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305891
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (b)(6).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 25 g x 1 in.Eclipse needle smartslip experienced leakage.The following information was provided by the initial reporter: whilst administering a subcutaneous injection of bortezomib (3mg in 1.2ml) when incident reporter and the patient felt a dribble near the injection site.They realized that some of the medication had leaked between the syringe and needle.The needle cannot have been fully screwed/fitted into the syringe.It is not possible to determine how much of the 1.2ml leaked out.There have been issues with this batch of orange needles bd eclipse with smartslip technology 25g.Washed the patient's hand and stomach thoroughly with soap and water and rinsed and dried both too.Bortezomib is neutral and not an irritant or vesicant.Explained to the patient that bortezomib is not a chemotherapy and is not likely to cause any skin irritation, but it was important to cleanse the skin.I told him to monitor his skin and stomach for any signs of irritation as a precaution.The patient asked if the treatment would need re-doing.Told patient no as it was not possible to determine how much leaked out and what dose was given.We did not want to give too much.The patient was discharged home.
Additional Manufacturer Narrative
Investigation summary a device history record review was completed for provided lot number 2102002.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, our quality engineer team was unable to complete a thorough sample analysis.Based on the investigation results, an exact cause could not be determined for this incident.
Event or Problem Description
It was reported that the 25 g x 1 in.Eclipse needle smartslip experienced leakage.The following information was provided by the initial reporter: whilst administering a subcutaneous injection of bortezomib (3mg in 1.2ml) when incident reporter and the patient felt a dribble near the injection site.They realized that some of the medication had leaked between the syringe and needle.The needle cannot have been fully screwed/fitted into the syringe.It is not possible to determine how much of the 1.2ml leaked out.There have been issues with this batch of orange needles bd eclipse with smartslip technology 25g.Washed the patient's hand and stomach thoroughly with soap and water and rinsed and dried both too.Bortezomib is neutral and not an irritant or vesicant.Explained to the patient that bortezomib is not a chemotherapy and is not likely to cause any skin irritation, but it was important to cleanse the skin.I told him to monitor his skin and stomach for any signs of irritation as a precaution.The patient asked if the treatment would need re-doing.Told patient no as it was not possible to determine how much leaked out and what dose was given.We did not want to give too much.The patient was discharged home.
Additional Manufacturer Narrative
The following fields were updated due to additional information: imdrf annex b grid: b02.H6: investigation summary: a device history record review was completed for provided lot number 2102002.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, our quality engineer team was unable to complete a thorough sample analysis.Twenty retained samples of the same lot number were obtained.The retained samples were assembled with a bd discardit syringe and no signs of defective hub connection or leakage were identified.Based on the investigation results, an exact cause could not be determined for this incident.
Event or Problem Description
It was reported that the 25 g x 1 in.Eclipse needle smartslip experienced leakage.The following information was provided by the initial reporter: whilst administering a subcutaneous injection of bortezomib (3mg in 1.2ml) when incident reporter and the patient felt a dribble near the injection site.They realized that some of the medication had leaked between the syringe and needle.The needle cannot have been fully screwed/fitted into the syringe.It is not possible to determine how much of the 1.2ml leaked out.There have been issues with this batch of orange needles bd eclipse with smartslip technology 25g.Washed the patient's hand and stomach thoroughly with soap and water and rinsed and dried both too.Bortezomib is neutral and not an irritant or vesicant.Explained to the patient that bortezomib is not a chemotherapy and is not likely to cause any skin irritation, but it was important to cleanse the skin.I told him to monitor his skin and stomach for any signs of irritation as a precaution.The patient asked if the treatment would need re-doing.Told patient no as it was not possible to determine how much leaked out and what dose was given.We did not want to give too much.The patient was discharged home.

• Brand Name: 25 G X 1 IN. ECLIPSE NEEDLE SMARTSLIP
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12407963
• Report Number: 3002682307-2021-00455
• Device Sequence Number: 14703079
• Product Code: FMI
• UDI-Device Identifier: 50382903058919
• UDI-Public: 50382903058919
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 05/31/2022

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: 01/31/2026
• Device Model Number: 305891
• Device Catalogue Number: 305891
• Device Lot Number: 2102002
• 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: 08/03/2021
• Supplement Date Received by Manufacturer: 11/08/2021; 05/31/2022
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 12/02/2021; 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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