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

Model Number	305616
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
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.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 two sharps coll slide close 9gal red were damaged and missing lids.The following information was provided by the initial reporter: "we received the sharps containers.2 were broken and they didn't have the lids with them.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2021-10-27.H6: investigation summary: a sample was received and there were no lids included with the customer's complaint.This verified the customer's stated issues.The information was then forwarded to the supplier for this issue and the sample was also sent.It can be concluded that there are too many variables that could have generated this failure mode due to the way the distributor handles product as they do partial sells.Also, the controls to handle remaining material is unknown.A dhr review could not be performed since lot number information was not received, the complaint information only contains the family product and item.However, a review of the ncmr¿s was performed; the result showed there were no issues reported for (damage bases or missing lids) for the same part number (305616) throughout the previous twelve months.
Event or Problem Description
It was reported two sharps coll slide close 9gal red were damaged and missing lids.The following information was provided by the initial reporter: "we received the sharps containers.2 were broken and they didn't have the lids with them.".

• Brand Name: SHARPS COLL SLIDE CLOSE 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12651457
• Report Number: 2243072-2021-02522
• Device Sequence Number: 1402261
• Product Code: FMI
• UDI-Device Identifier: 00382903056163
• UDI-Public: 00382903056163
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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