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

Model Number	305603
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.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 chemo 9gal yellow was missing lids.The following information was provided by the initial reporter: it was reported that the customer received 1 case of containers without lids.
Additional Manufacturer Narrative
H.6.Investigation: a complaint was received regarding missing lid(s) and investigation was completed with the information provided.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process for the lot 1102927 reported, additionally, a review of the ncmr¿s was performed; the result showed there were no issues reported like missing lids issue for the same part number throughout the last twelve months.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process because there is not enough information like method used to handle, shipped partial sells and controls to storage the remaining product within distributor facility.H3 other text : see h.10.
Event or Problem Description
It was reported that sharps coll chemo 9gal yellow was missing lids.The following information was provided by the initial reporter: it was reported that the customer received 1 case of containers without lids.

• Brand Name: SHARPS COLL CHEMO 9GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12038050
• Report Number: 2243072-2021-01721
• Device Sequence Number: 16368170
• Product Code: FMI
• UDI-Device Identifier: 00382903056033
• UDI-Public: 00382903056033
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K943140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/29/2021

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: 305603
• Device Catalogue Number: 305603
• Device Lot Number: 1102927
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1