MAUDE Adverse Event Report: BECTON DICKINSON SHARPS COLL 6GAL RED 1103 NON-VENT CAP; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305457
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacturer: 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.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 the sharps coll 6gal red 1103 non-vent cap broke/cracked when lifting the lid.The following information was provided by the initial reporter: "sharps container breaking/cracking when lifting lid.".
Additional Manufacturer Narrative
H6: investigation summary no photo or sample was received for the customer's complaint of broken lid.Without further information like a physical sample for investigation, the root cause of this failure remains unknown.Potential root cause 1.Non-controlled method to ship partial boxes to end user (re-packaging process).2.Non controlled handling within distributor facilities.The dhr review process can¿t be performed because the lot number wasn¿t provided.A review of the ncmr¿s was performed; the result showed there were no issues reported like lids or cracked issue for the same part number (305457) throughout the last twelve months.H3 other text : see h10.
Event or Problem Description
It was reported that the sharps coll 6gal red 1103 non-vent cap broke/cracked when lifting the lid.The following information was provided by the initial reporter: "sharps container breaking/cracking when lifting lid".

• Brand Name: SHARPS COLL 6GAL RED 1103 NON-VENT CAP
• 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: 12556903
• Report Number: 2243072-2021-02422
• Device Sequence Number: 4103056
• Product Code: FMI
• UDI-Device Identifier: 00382903054572
• UDI-Public: 00382903054572
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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: 305457
• Device Catalogue Number: 305457
• 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: 09/02/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/21/2021
• 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