MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 27X1/2; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305758
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that needle eclipse 27x1/2 caused a dirty needle stick.The following information was provided by the initial reporter: "bent cannula.The needle is distorted after use, causing the nurse to puncture.".
Event or Problem Description
It was reported that needle eclipse 27x1/2 caused a dirty needle stick.The following information was provided by the initial reporter: "bent cannula.The needle is distorted after use, causing the nurse to puncture".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-05-20.H.6.Investigation summary: two photos and one sample was received by our quality team for evaluation.Upon visual inspection it was observed that the cannula was bent; therefore, the incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.As per the complaint verbatim, the cannula was bent after application.The cannula stiffness was reviewed and within the specifications.Based on the investigation, the root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends h3 other text : see h.10.

• Brand Name: NEEDLE ECLIPSE 27X1/2
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10093622
• Report Number: 8041187-2020-00286
• Device Sequence Number: 2400433
• Product Code: FMI
• UDI-Device Identifier: 30382903057581
• UDI-Public: 30382903057581
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 09/30/2024
• Device Model Number: 305758
• Device Catalogue Number: 305758
• Device Lot Number: 9276551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/03/2020
• 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