MAUDE Adverse Event Report: BECTON DICKINSON BD¿ PHARMACEUTICAL WASTE COLLECTOR; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305622
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd¿ pharmaceutical waste collector the absorbing pad was missing.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the distributor that absorbent pad was not included with sharps collector.Verbatim: distributor: her customer states this pad was not included with the sharps collector they received.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.The manufacturing location for this product is flextronics.This site is an oem manufacturing site.(b)(4) medical device expiration date: unknown.Device manufacture date: unknown.Address information was not able to be obtained, therefore, nj was used as a place holder.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of missing absorbent pad could not be verified due to the product not being returned for failure investigation.According to the dhr review process; the result showed there were no issues reported like missing component (absorbing pad) during the manufacturing process of the part number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issue reported for missing component (absorbing pad) for the same part number throughout the last twelve months.According to the dhr review process; the result showed there were no issues reported like missing component (absorbing pad) during the manufacturing process of the part number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issue reported for missing component (absorbing pad) for the same part number throughout the last twelve months.Based on this investigation it was determined that this failure mode is related to the manufacturing process since the lack of absorbing pad could happen due to process omission since this component is attached manually.The current manufacturing process was reviewed and it was found as capable of detecting missing components such as absorbing pad.
Event or Problem Description
It was reported while using bd¿ pharmaceutical waste collector the absorbing pad was missing.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the distributor that absorbent pad was not included with sharps collector.Verbatim: distributor: her customer states this pad was not included with the sharps collector they received.

• Brand Name: BD¿ PHARMACEUTICAL WASTE COLLECTOR
• 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: 14957562
• Report Number: 2243072-2022-00916
• Device Sequence Number: 6896387
• Product Code: FMI
• UDI-Device Identifier: 00382903056224
• UDI-Public: 00382903056224
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K943141
• 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): 07/18/2022

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: 305622
• Device Catalogue Number: 305622
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/12/2022
• 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