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

Model Number	305609
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is flextronics.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: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 cases of bd¿ sharps collectors arrived without lids.The following information was provided by the initial reporter: "ordered 4 cases and 2 cases came without any lids.".
Additional Manufacturer Narrative
Investigation summary no product or photo was returned by the customer.It was reported the customer ordered 4 cases and 2 cases came without lids could not be verified due to the product not being returned for failure investigation.Based on the information provided, the device history record review process was unable to be performed since there was no lot number provided.A review of the ncmr¿s was performed; the result showed no issues reported for missing lids for the same part number throughout the last twelve months.According with this investigation, there is not enough information provided from customer like pictures of original packaging or lot number in order to determine the root cause of this issue.Within complaint report, it¿s mentioned that customer order four products and two of them came without lids.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 (cc) records was performed; according to the cc¿s records, ten additional complaints were received through the last twelve months for the same part number and issue.These previous complaints were closed as not manufacturing related/incomplete since there was not enough information provided from customer to determine the root cause.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.However potential root cause will be: 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non-controlled handling within distributor facilities.Based on information provided, it wasn¿t possible to determine the root cause like a failure mode related to the manufacturing process since there was not enough information provided like a picture from original packaging, lot number, method used to handle material, shipped partial sells and storage controls of the remaining product within distributors facilities to perform an exhaustive investigation.The current process controls were verified and confirmed as capable to detect missing lids.If additional information like a photo of original packaging used can be provided, then a new complaint record will be open to initiate a new investigation path.All the complaint information was captured also for tracking and trending purposes.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 2 cases of bd¿ sharps collectors arrived without lids.The following information was provided by the initial reporter: "ordered 4 cases and 2 cases came without any lids.".

• Brand Name: BD¿ SHARPS 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: 15505820
• Report Number: 2243072-2022-01686
• Device Sequence Number: 18100666
• Product Code: FMI
• UDI-Device Identifier: 00382903056095
• UDI-Public: (01)00382903056095
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/19/2022

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: 305609
• Device Catalogue Number: 305609
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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