MAUDE Adverse Event Report: BECTON DICKINSON BD¿ 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 Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: n/a.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.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 that a lid problem was found before use with a bd¿ sharps coll chemo 19gal yellow.The following information was provided by the initial reporter, "some of the containers were shorter and wider and would not fit on the trolleys.Also, some of the lids would not snap on securely." 4 occurrences were reported.
Event or Problem Description
It was reported that a lid problem was found before use with a bd¿ sharps coll chemo 19gal yellow.The following information was provided by the initial reporter, "some of the containers were shorter and wider and would not fit on the trolleys.Also, some of the lids would not snap on securely." 4 occurrences were reported.
Additional Manufacturer Narrative
H.6.Investigation: it was reported the containers are shorter and wider and wont fit in the trolleys.Also the lids will not snap on securely.No sample or picture was provided for evaluation.A review of the device history record (dhr) and non-conforming material report (ncmr) was performed for the last twelve months there were no issues reported like ¿lid doesn¿t close tight¿ during the manufacturing process.It is possible the arm of a trolley isn¿t properly placed.This cannot be confirmed however without the sample or pictures of the issue.The root cause was unconfirmed but could be related to arm placement during drilling process of defective trolley.This was a known manufacturing issue and an update to the manufacturing process instruction has been completed to prevent the issue from reoccurring.The issue could also be related to a misassembled slider or lid damage.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: 9856661
• Report Number: 2243072-2020-00448
• Device Sequence Number: 2900928
• Product Code: FMI
• UDI-Device Identifier: 50382903056137
• UDI-Public: 50382903056137
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 305613
• Device Lot Number: 9345925
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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