MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 21X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305765
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a visual inspection on damaged component qa outgoing inspection per mqa-052/a and visual inspection on damaged component at assembly in-process inspection per mfg-043/i.Actual root cause could not be determined as actual sample was not received for investigation.The complaint will be re-opened and re-investigated when sample is received.
Event or Problem Description
It was reported that bd needle eclipse 21x1-1/2 rb needle broke.It was reported by customer that the incident with an eclipse 21g 1 1/2 lot needle 1362829 exp 2026-12-31 that occurred at our clinic yesterday during the injection of a medication to one of our patients.Verbatim: rcc received a complaint via email.I would like to report an incident with an eclipse 21g 1 1/2 lot needle 1362829 exp 2026-12-31 that occurred at our clinic yesterday during the injection of a medication to one of our patients.Unfortunately, the defective needle was thrown into the needle container.It was impossible to get it back.Product number - 305765.Customer response received on 18-jun-2024.The translation of the customer response is: 1.Could you provide us with the exact date of the incident (in dd-mm-yyyy format)? (b)(6) 2024.2.Please describe any patient injury, injury, complication or adverse consequence of the incident.Patient did not receive full dose of antibiotic.Customer response received on 16-jul-2024.1.What was the flaw? during the intramuscular injection into the patient, the needle detached from the syringe.The nurse observed the breakage of the equipment at the needle thread (green part that screws to the syringe).2.What was the outcome for the patient? the patient did not get the full dose of the antibiotic.3.Which antibiotic was given? bicillin how much antibiotic was not given? it's difficult to assess.4.Has any additional treatment or care been provided? no.
Event or Problem Description
Material # 305765; batch # 1362829.It was reported by customer that the incident with an eclipse 21g 1 1/2 lot needle 1362829 exp 2026-12-31 that occurred at our clinic yesterday during the injection of a medication to one of our patients.Rcc received a complaint via email.I would like to report an incident with an eclipse 21g 1 1/2 lot needle 1362829 exp 2026-12-31 that occurred at our clinic yesterday during the injection of a medication to one of our patients.Unfortunately, the defective needle was thrown into the needle container.It was impossible to get it back.Product number 305765; customer response received on 18-jun-2024: the translation of the customer response is: could you provide us with the exact date of the incident (in dd-mm-yyyy format)? on (b)(6) 2024.Please describe any patient injury, injury, complication or adverse consequence of the incident.Patient did not receive full dose of antibiotic.Customer response received on 16-jul-2024.What was the flaw? during the intramuscular injection into the patient, the needle detached from the syringe.The nurse observed the breakage of the equipment at the needle thread (green part that screws to the syringe).What was the outcome for the patient? the patient did not get the full dose of the antibiotic.Which antibiotic was given? bicillin how much antibiotic was not given? it's difficult to assess.Has any additional treatment or care been provided? no.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a visual inspection on damaged component qa outgoing inspection and visual inspection on damaged component at assembly in-process inspection.Actual root cause could not be determined as actual sample was not received for investigation.The complaint will be re-opened and re-investigated when sample is received.

• Brand Name: BD NEEDLE ECLIPSE 21X1-1/2 RB
• 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: 19932337
• Report Number: 2243072-2024-00869
• Device Sequence Number: 15474590
• Product Code: FMI
• UDI-Device Identifier: 00382903057658
• UDI-Public: (01)00382903057658
• 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
• Report Date (Section B): 08/19/2024

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: Health Professional
• Device Catalogue Number: 305765
• Device Lot Number: 1362829
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown