MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE NEEDLE

Model Number	305758
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Investigation conclusion: unable to confirm the customer experience as no photo / sample is received for investigation.End user risk assessment as per (b)(4) document, (b)(4), the severity for safety mechanism failure is severe (s4) occurrence = (b)(4).The risk is acceptable per (b)(4).Root cause description: no photo/ sample were returned for investigation.Root cause could not be determined.The complaint will be re-opened and re-investigated if the sample is returned.Rationale: the complaint will continued to be tracked and monitored.
Event or Problem Description
It was reported that an unspecified number of bd eclipse¿ needles experienced safety mechanism failure and a safety mechanism that would not engage.It has not been specified whether the product defects were noted prior to, during, or after use.The following information was provided by the initial reporter: material no.305758 batch no.9081631.Complaint 2 of 2: this record reflects the #27 needle.Our l&d department has had multiple issues with the product #'s and lot #'s below; we cannot use them.They are not engaging properly; they get stuck at an angle.Our risk manager will be entering this into medsun.

• Brand Name: BD ECLIPSE NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10590934
• Report Number: 8041187-2020-00616
• Device Sequence Number: 19533949
• Product Code: FMI
• UDI-Device Identifier: 30382903057581
• UDI-Public: 30382903057581
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 03/31/2024
• Device Model Number: 305758
• Device Catalogue Number: 305758
• Device Lot Number: 9081631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/26/2020
• 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