MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS¿ COLLECTOR CHEMOTHERAPY 9 GAL YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305603
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/24/2019
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 bd sharps¿ collector chemotherapy 9 gal yellow came with no lids.The following information was provided by the initial reporter: material no.: 305603, batch no.: unknown.It was reported that no lids were received with the sharps container.
Additional Manufacturer Narrative
H.6.Investigation: no samples or pictures were received.The dhr review process was not able to perform due to the lot number was unknown.A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lids for the same part number throughout the last twelve months.According with this investigation there is no enough information provided from customer like a picture from the original packaging to determine the root cause of this non-conformance.Due to no samples or pictures were provided in this complaint, a review of customer complaint record was performed; according with the cc¿s records, no additional complaints were received through the last twelve months.Additionally, due to recurrences reported in the past about the same issue, corrective action was implemented within the manufacturing process to ensure the correct quantity of pieces per box (the corrective action was documented under capa record # ca-(b)(4) ).The corrective action consists in the implementation of a weighing system to determine the correct quantity of pieces per box through the weight of the pieces.H3 other text : see h.10.
Event or Problem Description
It was reported that bd sharps¿ collector chemotherapy 9 gal yellow came with no lids.The following information was provided by the initial reporter: material no.: 305603 batch no.: unknown.It was reported that no lids were received with the sharps container.

• Brand Name: BD SHARPS¿ COLLECTOR CHEMOTHERAPY 9 GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8683866
• Report Number: 2243072-2019-01145
• Device Sequence Number: 19318152
• Product Code: FMI
• UDI-Device Identifier: 00382903056033
• UDI-Public: 00382903056033
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/02/2019

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: 305603
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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