MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL CHEMO 19GAL YELLOW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305613
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: (b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or samples were received.Additional attempt to get more information was made, however, the customer confirmed that no additional information was available.According to the dhr review process, the result showed there were no issues reported as missing lids during the manufacturing process 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.According with this investigation there is not enough information provided from customer like pictures of original packaging in order to determine the root cause of this issue.This investigation can´t be completed due the lack of information provided but with the information collected of the report from the user ((b)(4) hospital) the investigation was concluded that this product had handling by a distributor due the package reported was for 5 pieces per case.The occurrence mentioned this issue in 1 piece, it can be concluded that there are many variables that could generate this failure mode because the distributors can do partial sells and the controls to handle remaining material is unknown; therefore, the likelihood of non-controlled handling within distributor facilities could happen.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.The controls were verified within the manufacturing process and confirmed as capable to detect the lack of missing lids.If additional information that helps to find the root cause can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.
Event or Problem Description
It was reported that the sharps coll chemo 19gal yellow had no lid.The following information was provided by the initial reporter, translated from (b)(6) to english: "the customer reported that the lid was missing.".

• Brand Name: SHARPS COLL CHEMO 19GAL YELLOW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 12569635
• Report Number: 2243072-2021-02443
• Device Sequence Number: 4094902
• Product Code: FMI
• UDI-Device Identifier: 00382903056132
• UDI-Public: 00382903056132
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

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: 305613
• Device Catalogue Number: 305613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1