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

Model Number	305635
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: 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.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 that bd sharps container had a difficult to close lid which resulted in a needle stick injury.There was no report of impact.The following information was provided by the initial reporter: " the sharps collector didn¿t work to dispose the unused product; when the nurse did recapping with both hands after supporting a patient to inject insulin, she pricked her finger on the needle.".
Event or Problem Description
It was reported that bd sharps container had a difficult to close lid which resulted in a needle stick injury.There was no report of impact.The following information was provided by the initial reporter: " the sharps collector didn¿t work to dispose the unused product; when the nurse did recapping with both hands after supporting a patient to inject insulin, she pricked her finger on the needle.".
Additional Manufacturer Narrative
H.6.Investigation: no samples or pictures were received.The dhr review was not able to be performed due to the lot number was not provided by customer.A review of the ncmr¿s was performed; the result showed there were no ncs generated for issues like wall thickness out of specification, deformation/damages on the lids that may cause defects that lead to injuries during the use on the same part number throughout the last twelve months.The complaint could not be performed and the root cause is undetermined.

• Brand Name: BD SHARPS CONTAINER
• 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: 13114128
• Report Number: 2243072-2021-03000
• Device Sequence Number: 16993152
• Product Code: FMI
• UDI-Device Identifier: 00382903056354
• UDI-Public: 00382903056354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2022

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: 305635
• Device Catalogue Number: 305635
• 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: 12/02/2021
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 04/20/2022
• 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