MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 19GAL YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305613
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 19gal yellow lids don't work properly.This occurred on 5 occasions before use.The following information was provided by the initial reporter: lids don't work smoothly.
Additional Manufacturer Narrative
H.6.Investigation summary: according to the dhr review process; the result showed there were no issues reported of lids not working smoothly during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported of lids not working smoothly for the same part number throughout the last twelve months.Based on information provided it wasn¿t possible determine the root cause like a failure mode related to the manufacturing process because there is not enough information like a picture from original packaging or samples to perform an exhaustive investigation.Also, it was noticed that this material was sold by a distributor, adding additional handling no controlled by flex.If additional information (photo of the case label and box and samples) that helps to find the root cause can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.H3 other text : see h.10.
Event or Problem Description
It was reported that sharps coll chemo 19gal yellow lids don't work properly.This occurred on 5 occasions before use.The following information was provided by the initial reporter: lids do not work smoothly.

• Brand Name: SHARPS COLL CHEMO 19GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10157997
• Report Number: 2243072-2020-00917
• Device Sequence Number: 16800689
• Product Code: FMI
• UDI-Device Identifier: 50382903056137
• UDI-Public: 50382903056137
• 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): 06/24/2020

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 Catalogue Number: 305613
• Device Lot Number: 9314901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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