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

Catalog Number	305613
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported prior to use the lid was discovered that lid would not close with a bd sharps¿ coll chemo 19gal yellow.The following information was provided by the initial reporter: it was reported that the lid will not close.Injuries or adverse event: no.
Event or Problem Description
It was reported prior to use the lid was discovered that lid would not close with a bd sharps¿ coll chemo 19gal yellow.The following information was provided by the initial reporter: it was reported that the lid will not close.Injuries or adverse event: no.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 5/28/2020 h.6.Investigation: the sample was received for an investigation.It was reported that the lid will not shut.However the sample provided was found shut and actually could not be opened.The lid was locked.A review of the device history record and non-conformance material report was performed and there were no issues reported like ¿lid will not close¿ for the same part number throughout the last twelve months and did not identify any nonconformance.Furthermore, the current process was evaluated and confirmed this set of lids are packaged with a plastic strap which prevents the permanent closure of the sliding door.A set of lids come packaged with a plastic strap which does not allow the final closure activation on the sliding door.There appears to have been a repackaging issue which occurred during distribution and was not related to the manufacturer.The root cause is incorrect packaging during distribution.The secure strap to keep the sliding door open was removed and the final closure was activated.H3 other text : see h.10.

• Brand Name: BD 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: 10052651
• Report Number: 2243072-2020-00765
• Device Sequence Number: 2400127
• Product Code: FMI
• UDI-Device Identifier: 50382903056137
• UDI-Public: 50382903056137
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: 9365918
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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