MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 9GAL GASKET RED; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305601
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the sharps coll 9gal gasket red was received without a lid.The following information was provided by the initial reporter: "reported issue: customer received box, unopened and not damaged without lids.".
Additional Manufacturer Narrative
H6: investigation summary: photo representation was provided.A review of the device history record (dhr) for the reported lot was performed and there were no issues found for missing lids during the manufacturing process of the reported lot.A review of non-conforming material report (ncmr) was performed for the last twelve months and did not identify any nonconformance.As corrective action a weighing system has already been implemented for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.All weight checks for this lot appear to have met requirements at the time of manufacturing with lids present.The root cause is unknown.This image of the box packaging tape does not appear to be original packaging tape.The lids could be misplaced, or an error occurred by a 3rd party if repackaging for distribution.This complaint may have occurred from a partial sale sold by the distributor.Additional information about the handling and storage by the distributor or user facility to rule out that the issue was not due to incorrect handling or a partial sale is required.Based on these findings, our investigation is inconclusive.
Event or Problem Description
It was reported that the sharps coll 9gal gasket red was received without a lid.The following information was provided by the initial reporter: "reported issue: customer received box, unopened and not damaged without lids.".

• Brand Name: SHARPS COLL 9GAL GASKET RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10805111
• Report Number: 2243072-2020-01798
• Device Sequence Number: 4329304
• Product Code: FMI
• UDI-Device Identifier: 00382903056019
• UDI-Public: 00382903056019
• 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): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305601
• Device Catalogue Number: 305601
• Device Lot Number: 0107923
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1