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

Model Number	305615
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Date of event: unknown.The date received by manufacturer has been used for this field.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 3 bd¿ sharps coll 9gal red were missing their lids.The following information was provided by the initial reporter: "missing the lids".
Additional Manufacturer Narrative
H.6.Investigation: photos representation was provided for the complaint of missing lids.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process for the lot number reported under this complaint (b)(4).A review of the ncmr¿s was performed; the result showed there were no issues reported like missing lids for the same part number throughout the last twelve months.Investigation : according with this investigation and the evidence received it can be seen the following: there are three lids missing from the product.We can confirm that lot number 2041910 was manufactured by flex on february 2022.With this information it cannot be determined this failure mode as related to the manufacturing process since a review of the weighing system records for the lot number provided was performed and no irregularity was detected.For this reason, it can be concluded that there are many variables that could generate this failure mode due to unknown handling and transportation, if the material is stored or if there are partial sales.Additional information is needed about the handling and storage within distributor facility to rule out that this issue was generated by distributors, because the distributors can do partial sells and the controls to handle remaining material is unknown, therefore, the likelihood that they send boxes with incorrect quantity could happen.In addition, the current manufacturing controls were reviewed, and they were confirmed as capable to detect this kind of issues (missing lids).As part of this investigation, a review of customer complaint records was performed; according with the cc¿s records, three additional complaints were received through the last twelve months for the same part number and issue.In the previous complaints it was concluded that the product was incorrect handle by the distributor, due to there is controls to prevent this failure mode within the manufacturing process.On basis of picture sample being received, an investigation performed and potential root cause will be: non-controlled method to ship partial boxes to end user (repackaging process).Non-controlled handling within distributor facilities.Based on the information provided, it was not possible to confirm the root cause like a failure mode related to the manufacturing process due to the lack of evidence and since acceptable records were found for each box manufactured of the lot number reported under this customer complaint during the review of the weighing system records (greater than the lowest validated limit under the weighing system).Information like packing used to ship material to the end user, method used to handle the material, partial sells and storage controls of the product within distributor facility will be needed in order to determine the root cause.H3 other text : see h.10.
Event or Problem Description
It was reported 3 bd¿ sharps coll 9gal red were missing their lids.The following information was provided by the initial reporter: "missing the lids".

• Brand Name: BD¿ SHARPS COLL 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14240228
• Report Number: 2243072-2022-00590
• Device Sequence Number: 4736794
• Product Code: FMI
• UDI-Device Identifier: 00382903056156
• UDI-Public: 00382903056156
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K943575
• 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): 06/07/2022

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: 305615
• Device Catalogue Number: 305615
• Device Lot Number: 2041910
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2022
• 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