MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305425
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 12 sharps coll side entry 5.4qt pearl 12/pk experienced difficult assembly with the lid not fitting on the collector.The following information was provided by the initial reporter: material no.305425, batch no.9026910.Per customer, containers do not fit.Lids are different than containers.
Event or Problem Description
It was reported that 12 sharps coll side entry 5.4qt pearl 12/pk experienced difficult assembly with the lid not fitting on the collector.The following information was provided by the initial reporter: material no.305425.Batch no.9026910.Per customer, containers do not fit.Lids are different than containers.
Additional Manufacturer Narrative
The actual product was returned, and photo representation was provided.A review of the dhr showed there were no issues reported like incorrect lids during the manufacturing process.A review of the nonconformance material reports was performed and the result showed there were no issues reported for the same part number throughout the last twelve months.According to the evidence provided, the issue seems to be related to an incorrect subassembly (box of lids) supplied, which is a manufacturing issue.In conclusion, a corrective action was not determined necessary at this time because of the low probability and the root cause was unconfirmed, but a quality alert has been posted within the manufacturing process for this issue.The issue will continue to be evaluated and monitored by bd for any trends.

• Brand Name: SHARPS COLL SIDE ENTRY 5.4QT PEARL 12/PK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8660543
• Report Number: 2243072-2019-01065
• Device Sequence Number: 2182957
• Product Code: FMI
• UDI-Device Identifier: 50382903054256
• UDI-Public: 50382903054256
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• 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): 06/28/2019

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: 305425
• Device Lot Number: 9026910
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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