MAUDE Adverse Event Report: BECTON DICKINSON 19GAL RED BD¿ EXTRA LARGE SHARPS COLLECTOR WITH CLEAR SLIDE TOP WITH GASKET; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305666
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	08/12/2019
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 flextronics.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 19gal red bd¿ extra large sharps collector with clear slide top with gasket lids were broken.This occurred on 3 occasions before use.No date/time or patient information was given.The following information was provided by the initial reporter: material no: 305666, batch no: unknown.It was reported that customer received 3 broken lids.Description: received a call stating that his customer received three lids broken lids.
Additional Manufacturer Narrative
Investigation summary: a review of the dhr was not performed since the lot number was unknown.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken for the same part number throughout the last twelve months.Based on the samples, the following observations were made: the lids were cracked from the edges.According with this investigation there is not enough information provided from customer like a picture from the original packaging in order to rule out that this product was damaged by incorrect handling, transportation or because a not suitable packaging was used (product repackaged within the distributor).Conclusion: based on information provided it wasn¿t possible determine the root cause like a failure mode related to the manufacturing process because there is no enough information like a picture from original packaging to perform an exhaustive investigation.
Event or Problem Description
It was reported that 19gal red bd¿ extra large sharps collector with clear slide top with gasket lids were broken.This occurred on 3 occasions before use.No date/time or patient information was given.The following information was provided by the initial reporter: material no: 305666 batch, no: unknown.It was reported that customer received 3 broken lids.Description: received a call stating that his customer received three lids broken lids.

• Brand Name: 19GAL RED BD¿ EXTRA LARGE SHARPS COLLECTOR WITH CLEAR SLIDE TOP WITH GASKET
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8935157
• Report Number: 2243072-2019-01814
• Device Sequence Number: 13535297
• Product Code: FMI
• UDI-Device Identifier: 50382903056663
• UDI-Public: 50382903056663
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• 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): 09/23/2019

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: 305666
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 09/23/2019
• 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