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

Catalog Number	305615
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: unknown.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 has been reported that one sharps coll 9gal red has been found missing the lid before use.The following has been provided by the initial reporter: it was reported that sharps collectors were missing lids.Verbatim: received 1 case w/8 bd sharps collectors.We did not receive the lids that were supposed to be included with collectors.
Additional Manufacturer Narrative
H.6.Investigation: a photo representation was received.Also, the evidence of original packaging was provided.The lids and the instructions for use are not observed in the photos with the total of eight containers.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, ¿missing lids¿.The photo provided may confirm repackaging by the distributor.A weighing system has already been implemented as corrective action for this container manufacturing process to ensure the correct quantity of pieces per box before shipping.Unfortunately, a weighted label placed on the original box by the weighing system is required to identify or confirm this type of issue.The root cause is unconfirmed.H3 other text : see h.10.
Event or Problem Description
It has been reported that one sharps coll 9gal red has been found missing the lid before use.The following has been provided by the initial reporter: it was reported that sharps collectors were missing lids.Verbatim: recieved 1 case w/8 bd sharps colletors.We did not recieve the lids that were supposed to be included with collectors.

• Brand Name: SHARPS COLL 9GAL RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9452204
• Report Number: 2243072-2019-02788
• Device Sequence Number: 2800426
• Product Code: FMI
• UDI-Device Identifier: 50382903056151
• UDI-Public: 50382903056151
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/24/2020

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 Catalogue Number: 305615
• Device Lot Number: 9183922
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/24/2020
• 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