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

Model Number	305616
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Medical device expiration date: unknown.Device manufacture date: unknown.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 while using bd sharps coll 9gal red the lid was missing.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, one lid was missing.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or samples were received.Additional attempt to get more information were made, however, the customer confirmed that no additional information was available.According to the dhr review, during the manufacturing process no issues were reported for missing lids for the part number reported under this complaint.A review of the ncmr¿s was performed; the results exhibit no issue reported for the same part number and issue throughout the last twelve months.According to the dhr review, during the manufacturing process no issues were reported for missing lids for the part number reported under this complaint.A review of the ncmr¿s was performed; the results exhibit no issue reported for the same part number and issue throughout the last twelve months.According with this investigation there is not enough information provided from customer such as lot number or pictures of the original packaging in order to determine the root cause of this issue.The variables that could generate this failure mode such as handling, transportation, storage or partial sales from distributor are unknown.Additional information is required to discard issue was generated by distributor facility, since partial sells and controls to handle remaining material is unknown, therefore, the likelihood of sending boxes with incorrect quantity exist.In addition, the current manufacturing controls were reviewed, and confirmed the capability to detect this type of issue (missing lids).As part of this investigation, a review of customer complaint records was performed; according to the cc¿s records, six additional complaints were received through the last twelve months for the same part number and issue.These previous complaints were closed as non-manufacturing related and incomplete since there was not enough information provided from customer to determine the root cause.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process since there is not enough information such as 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 reporting failure mode.If additional information that would help to determine the root cause can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured for tracking and trending purposes.H3 other text : see h10.
Event or Problem Description
It was reported while using bd sharps coll 9gal red the lid was missing.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, one lid was missing.

• 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: 15523298
• Report Number: 2243072-2022-01709
• Device Sequence Number: 20340672
• Product Code: FMI
• UDI-Device Identifier: 00382903056163
• UDI-Public: 00382903056163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 305616
• Device Catalogue Number: 305616
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 10/24/2022
• 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