MAUDE Adverse Event Report: BECTON DICKINSON BD¿ LARGE SHARP COLLECTOR, RED, LIQUID ABSORBING PAD, 34L; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 of the bd¿ large sharp collector, red, liquid absorbing pad, 34l were broken at the bottom.The following information was provided by the initial reporter: the shipper is intact however the material is broken at bottom for cat no.305615.
Additional Manufacturer Narrative
The manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in manufacturer name, city and state and mfr site and the franklin lakes fda registration number has been used for the manufacture report number.Device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 of the bd¿ large sharp collector, red, liquid absorbing pad, 34l were broken at the bottom.The following information was provided by the initial reporter: the shipper is intact however the material is broken at bottom for cat no.305615.
Additional Manufacturer Narrative
No sample received but photos representation was provided for the complaint.It was reported by customer that the shipper is intact however the material is broken at bottom for mat #305615.According to the device history record review process, no issues reported as damaged base during the manufacturing process of the lot number 2138973.Also, a review of the non-conformance material report was performed; the result showed no issues reported for the same issue and part number throughout the last twelve months within our process.H3 other text : see h10.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Becton dickinson and company's (bd) medication delivery solutions (mds) business unit will discontinue malfunction mdr reporting for certain device failures that have not caused or contributed to deaths or serious injuries in the past two years, and where the likelihood of a death or serious injury as a result of these malfunctions is remote.This decision follows fda guidelines (medical device reporting for manufacturers guidance for industry and food and drug administration staff issued nov 8, 2016, reference section 2.15).Bd notified fda of this decision on mar 3, 2025.Fda has reviewed and responded to bd¿s notification (reference fda document#: (b)(4) on march 7, 2025.This documentation is available in bd document management system (sap) as (b)(4).This supplemental mdr is being filed to document that the below device failure will no longer be considered a reportable malfunction mdr for the product family below: product family: sharp collectors, device failure: base broken / damaged / defective.

• Brand Name: BD¿ LARGE SHARP COLLECTOR, RED, LIQUID ABSORBING PAD, 34L
• 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 ; 8448235433
• MDR Report Key: 16695012
• Report Number: 2243072-2023-00572
• Device Sequence Number: 3629064
• Product Code: FMI
• UDI-Device Identifier: 00382903056156
• UDI-Public: (01)00382903056156
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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: 305615
• Device Catalogue Number: 305615
• Device Lot Number: 2138973
• 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: 03/18/2023
• Supplement Date Received by Manufacturer: 04/26/2023; Not provided
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/10/2023; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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