MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL SLIDE CLOSE 19GAL PHARM; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305328
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is not registered with the fda.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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the sharps coll slide close 19gal pharm was missing its lid.The following information was provided by the initial reporter: "rma above was called in by customer service due to customer complaint of " missing lids"".
Event or Problem Description
It was reported that the sharps coll slide close 19gal pharm was missing its lid.The following information was provided by the initial reporter: "rma above was called in by customer service due to customer complaint of " missing lids"".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-08.H6: investigation summary: samples were received and investigated by our supplier.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.Potential root cause: non-controlled method to ship partial boxes to end user (re-packaging process).Non controlled handling within distributor facilities.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.H3 other text: see h10.

• Brand Name: SHARPS COLL SLIDE CLOSE 19GAL PHARM
• 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: 12451037
• Report Number: 2243072-2021-02277
• Device Sequence Number: 19678738
• Product Code: FMI
• UDI-Device Identifier: 50382903053280
• UDI-Public: 50382903053280
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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,Distributor
• 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: 305328
• Device Catalogue Number: 305328
• Device Lot Number: 1204919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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