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

Model Number	305616
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Device manufacture date: unknown.
Event or Problem Description
It was reported that sharps coll slide close 9gal red was missing lid.This occurred on 20 occasions.The following information was provided by the initial reporter: this is a report about missing lids of sharps collectors.According to the customer's report, 480 products arrived with 20 lids missing.
Event or Problem Description
It was reported that sharps coll slide close 9gal red was missing lid.This occurred on 20 occasions.The following information was provided by the initial reporter: this is a report about missing lids of sharps collectors.According to the customer's report, 480 products arrived with 20 lids missing.
Additional Manufacturer Narrative
H6: investigation summary 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 the evidence received, this investigation can´t be completed due the lack of information provided but with the information collected of the report from the user the investigation was concluded that this product had handling by a distributor due the package reported was for 8 pieces but the occurrence only mentioned this issue in 20 piece (2.5 cases) and the package of lids have a plastic band to avoid losing any lid.For this reason, 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.H3 other text : see h10.

• Brand Name: SHARPS COLL SLIDE CLOSE 9GAL RED
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12516140
• Report Number: 2243072-2021-02371
• Device Sequence Number: 11634853
• Product Code: FMI
• UDI-Device Identifier: 00382903056163
• UDI-Public: 00382903056163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2022

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: 305616
• Device Catalogue Number: 305616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown