MAUDE Adverse Event Report: BECTON DICKINSON BD¿ LARGE SHARP COLLECTOR, RED, LIQUID ABSORBING PAD, 34L; 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	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Medical device expiration date: unknown.Initial reporter address 1: (b)(6).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 prior to using the bd¿ large sharp collector, red, liquid absorbing pad, 34l, the lids were missing.The following information was provided by the initial reporter: reported issue: missing lids.
Event or Problem Description
It was reported that prior to using the bd¿ large sharp collector, red, liquid absorbing pad, 34l, the lids were missing.The following information was provided by the initial reporter: reported issue: missing lids.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 03-may-2022.H.6.Investigation: photos representation was provided for the complaint.Sample was received and investigation performed.According to the dhr review process, the result showed there were no issues reported like missing lids during the manufacturing process.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.According with this investigation and evidence received, it can be seen the following: there are lids missing from the package.We can confirm the lot number 2032953 was manufactured by flex on 02/01/2022.The product is in its original packaging.There were received 8 sharps containers without lids returned in vernon hills.With this information it can¿t be concluded this failure mode as related to the manufacturing process since the review of the weighing system records for the lot number provided (2032953) was made and no irregularity was detected.There are many variables that can generate this failure mode due to unknown handling and transportation by the distributor when sending the product to the customer, if the material is stored, if there are partial sales or if there were mishandling during the customs review.Additional information on handling and storage within the distributor's facilities is needed to rule out that this problem has been generated by the distributors, since distributors may make partial sales and the controls to handle the remaining material are unknown, therefore, the probability that they send boxes with incorrect quantities could happen.Additionally, as part of the investigation, a review of customer complaint records was conducted according to qc records, two complaints were received during the last twelve months for the same part number and problem.Based on the information provided, it was determined that this failure mode is not related to the manufacturing process since acceptable records were found for each box manufactured (greater than the lowest validated limit under the weighing system) of the lot number reported under this customer complaint.

• Brand Name: BD¿ LARGE SHARP COLLECTOR, RED, LIQUID ABSORBING PAD, 34L
• 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: 14290237
• Report Number: 2243072-2022-00621
• Device Sequence Number: 1532366
• Product Code: FMI
• UDI-Device Identifier: 00382903056156
• UDI-Public: 00382903056156
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,User Facility
• 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: 2032953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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