MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 3GAL YELLOW NEW CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305076
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Medical device expiration date: na.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 sharps coll chemo 3gal yellow new cap lid was damaged.The following information was provided by the initial reporter: according to the customer's report, the dual-opening top of the lid wad damaged at its hinge.
Event or Problem Description
It was reported that sharps coll chemo 3gal yellow new cap lid was damaged.The following information was provided by the initial reporter: according to the customer's report, the dual-opening top of the lid wad damaged at its hinge.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-01-08.H6: investigation summary: it was reported that the dual-opening top of the lid was damaged at its hinge.Bdj received an actual sample and the issue was confirmed.The lid was broken at the position of the hinge.Pictures identifying the issue were provided for a supplier investigation.A device history review was conducted for lot number 0136003.The supplier identified no non conformance results during the production of this lot.All testing was within specification.It does not appear the issue was related to the manufacturing process.A root cause for the complaint was undetermined.The issue was most likely related to transportation and may have been damaged in transit.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences and captured through the quality data analysis (qda) process.H3 other text : see h10.

• Brand Name: SHARPS COLL CHEMO 3GAL YELLOW NEW CAP
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11190295
• Report Number: 2243072-2021-00138
• Device Sequence Number: 18993218
• Product Code: FMI
• UDI-Device Identifier: 50382903050760
• UDI-Public: 50382903050760
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943140
• 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): 02/07/2021

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 Model Number: 305076
• Device Catalogue Number: 305076
• Device Lot Number: 0136003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1