MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 17GAL YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305614
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Medical device expiration date: na.The customer's address is unknown.(b)(6) usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that sharps coll chemo 17gal yellow lid was missing.The following information was provided by the initial reporter: material no.: 305614 batch no.: 0205920.It was reported the lids are missing.
Additional Manufacturer Narrative
H.6.Investigation: sample and photo representation was provided.The issue was confirmed and there was missing lids with sample not packaged according to specification however we could not confirm the root cause.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.The root cause is unknown.The lids could be misplaced, or an error occurred by a 3rd party if repackaging for distribution.It was noticed that this material was sold by a distributor (henry schein).This complaint may have occurred from a partial sale sold by the distributor.Additional information is needed about the handling and storage by the distributor facility to rule out that the issue was not due to incorrect handling or a partial sale.Based on these findings, our investigation is inconclusive.
Event or Problem Description
It was reported that sharps coll chemo 17gal yellow lid was missing.The following information was provided by the initial reporter: material no.: 305614 batch no.: 0205920 it was reported the lids are missing.

• Brand Name: SHARPS COLL CHEMO 17GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11032875
• Report Number: 2243072-2020-02087
• Device Sequence Number: 1256858
• Product Code: FMI
• UDI-Device Identifier: 00382903056149
• UDI-Public: 00382903056149
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• 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): 01/08/2021

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: 305614
• Device Catalogue Number: 305614
• Device Lot Number: 0205920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1