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

Model Number	305604
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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: 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 slide close chemo 9gal lid was missing.The following information was provided by the initial reporter: lids were missing.
Additional Manufacturer Narrative
Investigation summary: a sample was received and tested by our quality team.The customer's complaint of missing lids was verified as there were 8 bins but no lids.This complaint was then forwarded to the supplier for further investigation and possible root cause realization.Potential root cause: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non controlled handling within distributor facilities.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process of the lot number reported under this customer complaint.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.H3 other text : see h10.
Event or Problem Description
It was reported that sharps coll slide close chemo 9gal lid was missing.The following information was provided by the initial reporter: lids were missing.

• Brand Name: SHARPS COLL SLIDE CLOSE CHEMO 9GAL
• 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: 12586569
• Report Number: 2243072-2021-02454
• Device Sequence Number: 14266752
• Product Code: FMI
• UDI-Device Identifier: 00382903056040
• UDI-Public: 00382903056040
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/01/2021

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: 305604
• Device Catalogue Number: 305604
• Device Lot Number: 1177908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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