MAUDE Adverse Event Report: BECTON DICKINSON BD SHARPS CONTAINER 1.4 QT HOME; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	323487
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as premium plastic solutions is an oem manufacturing site.Date of event: unknown.The date received by manufacturer has been used for this field."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7326001, medical device expiration date: n/a, device manufacture date: 2017-11-30, medical device lot #: 8089001, medical device expiration date: n/a, device manufacture date: 2018-04-10." a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that lid was missing with a bd sharps container 1.4 qt home.The following information was provided by the initial reporter: it was reported that home sharps containers were missing lids.
Event or Problem Description
It was reported that lid was missing with a bd sharps container 1.4 qt home.The following information was provided by the initial reporter: it was reported that home sharps containers were missing lids.
Additional Manufacturer Narrative
H.6.Investigation summary: level a investigation: complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for lid missing on lot # 7326001 and lot # 8089001.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.As per the attached dhrs, no ncrs were raised during the production of the reported lots.All testing was within specifications.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.H3 other text : see h 10.

• Brand Name: BD SHARPS CONTAINER 1.4 QT HOME
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8965522
• Report Number: 2243072-2019-01910
• Device Sequence Number: 11586881
• Product Code: FMI
• UDI-Device Identifier: 10885403960109
• UDI-Public: 10885403960109
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: Lay User/Patient
• Device Catalogue Number: 323487
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 08/17/2019
• Supplement Date Received by Manufacturer: 08/17/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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