MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X5/8; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305759
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 25x5/8 leaked the following information was provided by the initial reporter: it was reported by the customer that they noticed the medication was leaking out.Rcc received a complaint via email.Email(s) attached.Quality issue product performance (leaking) when the nurses start injecting medications, they noticed the medication was leaking out.No patient injury reported.On (b)(6) ¿ towards the completion of a subcutaneous injection of chemotherapy (bortezomib), i noted a single small drop of the drug that leaked onto the patient's skin as i was slowly injecting the drug.I immediately stopped pushing on the syringe plunger to prevent loss of any more drug / fluid.On (b)(6) ¿ atropine leaked out of the syringe.The needle would not connect properly with the syringe.On (b)(6) ¿ one drop of bortezomib came out of connection of the needle and equashield, unable to estimate how much in volume.On (b)(6) ¿ vitamin b12 injection being administered to pt.Lot # 2011005 25g x 5/8 needle adapter (bd eclipse needle) was used during administration.Upon administration writer noticed minimal leakage at connection site between needle adaptor and syringe.Administration stopped.Feb 2 - rn went to connect 25g needle to 10mls syringe of daratumumab and needle would not secure properly on the syringe.Rn attempted several times to secure needle on syringe tip but would not make properly seal.Lot#: 2011005 2011009 2007005 product#: 305759.
Event or Problem Description
Material#: 305759 , lot#: 2011005 ,2011009, 2007005.It was reported by the customer that they noticed the medication was leaking out.Verbatim: rcc received a complaint via email.Email(s) attached.Quality issue product performance (leaking).When the nurses start injecting medications, they noticed the medication was leaking out.No patient injury reported.On (b)(6) ¿ towards the completion of a subcutaneous injection of chemotherapy (bortezomib), i noted a single small drop of the drug that leaked onto the patient's skin as i was slowly injecting the drug.I immediately stopped pushing on the syringe plunger to prevent loss of any more drug / fluid.On (b)(6)¿ atropine leaked out of the syringe.The needle would not connect properly with the syringe.On (b)(6) ¿ one drop of bortezomib came out of connection of the needle and equashield, unable to estimate how much in volume.On (b)(6) ¿ vitamin b12 injection being administered to pt.Lot # 2011005 25g x 5/8 needle adapter (bd eclipse needle) was used during administration.Upon administration writer noticed minimal leakage at connection site between needle adaptor and syringe.Administration stopped.On feb 2 - rn went to connect 25g needle to 10mls syringe of daratumumab and needle would not secure properly on the syringe.Rn attempted several times to secure needle on syringe tip but would not make properly seal.Lot#: 2011005, 2011009, 2007005.Product#: 305759.Follow up: 1.Please confirm the exact location of leakage/damage.My understanding is that a needle would not connect/screw with a syringe properly.Medications are leaking out where the needle is connected to the syringe.No minor damage to anyone, but we are injecting cytotoxic drugs at our clinic.This is a huge hazard for both providers (nurses) and the patients.2.Please confirm a product is still operable or not? no.Due to the leakage, the product is not operable.The user (nurses) won't be able to give a full dose.3.Did the event directly, or indirectly involve a patient or user? yes, a direct impact on the patients.Due to the leakage, the patients won't be able to receive a full dose.4.If patient impact, please provide any available patient information including: age/ date of birth, sex, weight, ethnicity, race, other relevant history including preexisting medical conditions.I don't think this is a relevant information to these incidents.2 out of 5 patients were receiving bortezomib injection which is a treatment for multiple myeloma 5.Is there any physical sample or sample photos/videos available? if yes, kindly share it for investigation.No.6.Can you please share the batch number according to date of event? because for this complaint there is 5 date of event and 3 lot numbers provided.On dec 5 2023 - 2011009.On dec 12 2023 - 2011005.On nov 30 2023 - unknown.On dec 18 2023 - 2011005.On feb 2 2024 - 2007005.7.Can please provide the customer address for samples? (b)(6).
Additional Manufacturer Narrative
Current control there is an inspection on hub leak test assembly at the qa outgoing inspection.Actual root cause could not be determined as no sample were received for investigation.The complaint will be re-opened and re-investigated when sample is received.H3 other text : see h10 manufacture narrative.
Additional Manufacturer Narrative
Correction: event date added nov 30 2023.
Event or Problem Description
Material#: 305759 , lot#: 2011005 ,2011009, 2007005.It was reported by the customer that they noticed the medication was leaking out.Verbatim: rcc received a complaint via email.Email(s) attached.Quality issue product performance (leaking).When the nurses start injecting medications, they noticed the medication was leaking out.No patient injury reported.On (b)(6) ¿ towards the completion of a subcutaneous injection of chemotherapy (bortezomib), i noted a single small drop of the drug that leaked onto the patient's skin as i was slowly injecting the drug.I immediately stopped pushing on the syringe plunger to prevent loss of any more drug / fluid.On (b)(6) ¿ atropine leaked out of the syringe.The needle would not connect properly with the syringe.On dec 12 ¿ one drop of bortezomib came out of connection of the needle and equashield, unable to estimate how much in volume.On (b)(6) ¿ vitamin b12 injection being administered to pt.Lot # 2011005 25g x 5/8 needle adapter (bd eclipse needle) was used during administration.Upon administration writer noticed minimal leakage at connection site between needle adaptor and syringe.Administration stopped.On (b)(6) - rn went to connect 25g needle to 10mls syringe of daratumumab and needle would not secure properly on the syringe.Rn attempted several times to secure needle on syringe tip but would not make properly seal.Lot#: 2011005, 2011009, 2007005.Product#: 305759.Follow up: 1.Please confirm the exact location of leakage/damage.My understanding is that a needle would not connect/screw with a syringe properly.Medications are leaking out where the needle is connected to the syringe.No minor damage to anyone, but we are injecting cytotoxic drugs at our clinic.This is a huge hazard for both providers (nurses) and the patients.2.Please confirm a product is still operable or not? no.Due to the leakage, the product is not operable.The user (nurses) won't be able to give a full dose.3.Did the event directly, or indirectly involve a patient or user? yes, a direct impact on the patients.Due to the leakage, the patients won't be able to receive a full dose.4.If patient impact, please provide any available patient information including: age/ date of birth, sex, weight, ethnicity, race, other relevant history including preexisting medical conditions.I don't think this is a relevant information to these incidents.2 out of 5 patients were receiving bortezomib injection which is a treatment for multiple myeloma 5.Is there any physical sample or sample photos/videos available? if yes, kindly share it for investigation.No.6.Can you please share the batch number according to date of event? because for this complaint there is 5 date of event and 3 lot numbers provided.(b)(6) 2023 - 2011009.(b)(6) 2023 - 2011005.(b)(6) 2023 - unknown.(b)(6) 2023 - 2011005.(b)(6) 2024 - 2007005.7.Can please provide the customer address for samples? (b)(6).

• Brand Name: BD NEEDLE ECLIPSE 25X5/8
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18803520
• Report Number: 2243072-2024-00225
• Device Sequence Number: 7310758
• Product Code: FMI
• UDI-Device Identifier: 30382903057598
• UDI-Public: (01)30382903057598
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2024

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: 305759
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 03/21/2024; 03/21/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 03/22/2024; 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown