MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL WALLMATE 5.4QT BEIGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305550
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
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: n/a.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that sharps coll wallmate 5.4qt beige was broken.This was discovered before use.The following information was provided by the initial reporter: material no: 305550 batch no: 9210930.It was reported that the product was broken.
Event or Problem Description
It was reported that sharps coll wallmate 5.4qt beige was broken.This was discovered before use.The following information was provided by the initial reporter: material no: 305550 batch no: 9210930 it was reported that the product was broken.
Additional Manufacturer Narrative
H.6.Investigation summary a sample and photo representation was provided, and additional evidence of original packaging was available.A review of the device history record (dhr) and non-conforming material report (ncmr) for the reported lot was performed for the past 12 months.There were no manufacturing or material defects reported that could have caused or contributed to the reported incident.An investigation was performed to review the current manufacturing processes.All material is 100% inspected by the production department.Also, a second inspection is performed based on an aql sampling plan by a quality auditor.It is likely that the damage occurred after distribution and was damaged in transit during shipping or handling.Bd will continue to monitor the complaint for any trends.H3 other text : see section h.10.

• Brand Name: SHARPS COLL WALLMATE 5.4QT BEIGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9591215
• Report Number: 2243072-2020-00038
• Device Sequence Number: 3341320
• Product Code: FMI
• UDI-Device Identifier: 50382903055505
• UDI-Public: 50382903055505
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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 Model Number: 305550
• Device Catalogue Number: 305550
• Device Lot Number: 9210930
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/19/2020
• 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