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

Catalog Number	305767
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.305767, batch no.9028588.It was reported that during use of the bd eclipse¿ needle the nurse stuck the patient and the needle would not deliver the medication.The term in verbatim "broke" is related to needle being clogged, because once the needle was changed the medication was delivered.This occurred on 2 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: 2 separate incidents where the nurse stuck the patient and the needle broke.Customer provided response to information requested but information was unclear.Sent customer additional email to clarify information.I don't have the date of the additional occurrence (it was within the last 6 months).The needle did not break.The medication in the syringe could not be pushed through the lumen of the needle.The needle had to withdrawn from the joint space and a different needle used to administer the medication.(b)(6) 2019.Customer called me to explain answers to additional information requested, was told date of event should not be (b)(6) it should be (b)(6) with the patient identifiers provided in email recvd (b)(6) she did not have patient identifiers or a date of event for the second incident so that will remain as unknown.Customer also stated needle was blocked for both incidents and once needle was changed on the syringe in use the issue was resolved.Therefore no syringe complaint needs to be opened.Customer also sent email with information stating "a different needle was attached to the same syringe and the medication was administered into a joint space (knee) without difficulty.".
Additional Manufacturer Narrative
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
Material no.305767.Batch no.9028588.It was reported that during use of the bd eclipse¿ needle the nurse stuck the patient and the needle would not deliver the medication.The term in verbatim "broke" is related to needle being clogged, because once the needle was changed the medication was delivered.This occurred on 2 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: 2 separate incidents where the nurse stuck the patient and the needle broke.Customer provided response to information requested but information was unclear.Sent customer additional email to clarify information.I don't have the date of the additional occurrence (it was within the last 6 months).The needle did not break.The medication in the syringe could not be pushed through the lumen of the needle.The needle had to withdrawn from the joint space and a different needle used to administer the medication.(b)(6) 2019- customer called me to explain answers to additional information requested, was told date of event should not be (b)(6) it should be (b)(6) with the patient identifiers provided in email recvd (b)(6), she did not have patient identifiers or a date of event for the second incident so that will remain as unknown.Customer also stated needle was blocked for both incidents and once needle was changed on the syringe in use the issue was resolved.Therefore no syringe complaint needs to be opened.Customer also sent email with information stating "a different needle was attached to the same syringe and the medication was administered into a joint space (knee) without difficulty.".

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9386582
• Report Number: 8041187-2019-00961
• Device Sequence Number: 19496787
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: 30382903057673
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (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): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 305767
• Device Lot Number: 9028588
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 155