MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1-1/2 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305765
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that needle eclipse 21x1-1/2 rb tw cannula and the safety shield were protruding through the package.This was discovered before use.The following information was provided by the initial reporter: material no.: 305765, batch no.: 8171369.It was reported when the customer responded to an information request for a previous complaint they stated they also had product that had the needle and safety shield protruding out of the package.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes, returned to manufacturer on: 2020-06-01 h.6.Investigation summary one photo and five physical samples were received for investigation.From the photo, the part protruding out of the package and damaged sealing was observed.From the five samples received, one of the samples was observed to have the part protruding out of the package and damage sealing.This sample was located in the middle of the unit blister strip.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.A review of the packaging process showed that the damage could have occurred during product insertion to the shelf carton.In this process, there are two grippers with three fingers at the top and bottom to guide the product into the shelf carton.The middle gripper finger could have bent, hitting the part causing the bottom web and hub damage.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that needle eclipse 21x1-1/2 rb tw cannula and the safety shield were protruding through the package.This was discovered before use.The following information was provided by the initial reporter: material no.: 305765 batch no.:8171369 it was reported when the customer responded to an information request for a previous complaint they stated they also had product that had the needle and safety shield protruding out of the package.

• Brand Name: NEEDLE ECLIPSE 21X1-1/2 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10112282
• Report Number: 8041187-2020-00317
• Device Sequence Number: 19473252
• Product Code: FMI
• UDI-Device Identifier: 30382903057659
• UDI-Public: 30382903057659
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• 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,Followup
• Report Date (Section B): 06/16/2020

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: 06/30/2023
• Device Model Number: 305765
• Device Catalogue Number: 305765
• Device Lot Number: 8171369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 06/17/2020
• 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