MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305457
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	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd sharps collector lids are damaged.This was discovered before use.The following information was provided by the initial reporter: material no.305457 batch no.Unknown.It was reported several of the sharp container lids are cracked or broken.I just had a call from one of our customers about 6 gal.Sharps container.The problem they are having is they are ordering a case of this and by the time they receive it several of the lids are cracked or broken.I let him know we would try to get this taken care of on our end, so could you reach out to the vendor and see if they can package the lids in a better way maybe? layered in bubble wrap? layered in foam? i don't know.Just enough so they can ensure the lids wont get damaged anymore.Please let me know if you can do this and fill customer service in so we can be aware as well.
Event or Problem Description
It was reported that bd sharps collector lids are damaged.This was discovered before use.The following information was provided by the initial reporter: material no.305457 batch no.Unknown it was reported several of the sharp container lids are cracked or broken.I just had a call from one of our customers about 6 gal.Sharps container.The problem they are having is they are ordering a case of this and by the time they receive it several of the lids are cracked or broken.I let him know we would try to get this taken care of on our end, so could you reach out to the vendor and see if they can package the lids in a better way maybe? layered in bubble wrap? layered in foam? idk.Just enough so they can ensure the lids wont get damaged anymore.Please let me know if you can do this and fill customer service in so we can be aware as well.
Additional Manufacturer Narrative
Investigation summary: the actual product nor photo representation was provided.A review of the device history record (dhr) was not possible since a lot number could not be provided.Also, a review of non-conforming material report (ncmr) for the reported container was performed for the past 12 months and no manufacturing or material defects were identified that could have caused or contributed to the reported incident, broken and damaged lids.A review of the current manufacturing process and controls was completed, and an inspection is performed by production, and a visual and functional inspection based on an aql sampling plan is performed by a quality auditor.Additionally, a complaint history review was performed and only one other complaint was identified for the same issue related to repackaging however a root cause was unconfirmed.It is possible that damage occurred in transit during shipping or during the package handling to fulfill partial sales by the distributor.Bd will continue to monitor the complaint for any trends.H3 other text : see section h.10.

• Brand Name: BD SHARPS COLLECTOR
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9280568
• Report Number: 2243072-2019-02458
• Device Sequence Number: 19457857
• Product Code: FMI
• UDI-Device Identifier: 50382903054577
• UDI-Public: 50382903054577
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K943134
• 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): 12/04/2019

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: 305457
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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