MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305757
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 5 bd eclipse¿ needles were clogged during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we have come across many that have no bore to them (opening).Additional information received on (b)(6) 2023.Could you please clarify if the ¿no bore to them (opening)¿ statement indicates that the needle tip has no hole? yes.Please describe in detail what was the issue occurred with the defective needle.The needle tips had no hole.There were multiple needles with no hole - 5+.Could you please advise if defect was found before use or during use or after use? during use.Was there any patient involvement? are there any adverse events/serious injuries? 2 patient involvement.No injuries as we replaced needle until we found one that was working.Additional information received on (b)(6) 2023.I cannot recall who the patients were as it happened in a span of two days during a surgical biopsy procedure for those patients so of course we were in a bit of an emergency situation to get it fixed (changing out the needles until we got a good one).We were using local anesthesia (lidocaine with epinepherine) to numb the patient for biopsy procedure.".
Additional Manufacturer Narrative
H6: 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 number 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.
Event or Problem Description
It was reported that 5 bd eclipse¿ needles were clogged during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "we have come across many that have no bore to them (opening).Additional information received on 13-april-2023.1.Could you please clarify if the ¿no bore to them (opening)¿ statement indicates that the needle tip has no hole? yes 2.Please describe in detail what was the issue occurred with the defective needle.The needle tips had no hole.There were multiple needles with no hole - 5+.3.Could you please advise if defect was found before use or during use or after use? during use.6.Was there any patient involvement? are there any adverse events/serious injuries? 2 patient involvement.No injuries as we replaced needle until we found one that was working additional information received on 14-april-2023.I cannot recall who the patients were as it happened in a span of two days during a surgical biopsy procedure for those patients so of course we were in a bit of an emergency situation to get it fixed (changing out the needles until we got a good one).We were using local anesthesia (lidocaine with epinephrine) to numb the patient for biopsy procedure.".

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16869674
• Report Number: 8041187-2023-00193
• Device Sequence Number: 14822301
• Product Code: FMI
• UDI-Device Identifier: 00382903057573
• UDI-Public: 00382903057573
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 305757
• Device Lot Number: 2150679
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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