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

Model Number	305602
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 5 bd¿ sharps collectors' gaskets were defective and pulled apart easily.The following information was provided by the initial reporter: "cust states defective.No elasticity pulls apart like paper.".
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.The reported lot# am7316a83 was not found for the reported catalog# 305602.Medical 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.Device manufacture date: unknown.
Event or Problem Description
It was reported that 5 bd¿ sharps collectors' gaskets were defective and pulled apart easily.The following information was provided by the initial reporter: "cust states defective.No elasticity pulls apart like paper.".
Additional Manufacturer Narrative
Investigation summary no photos or physical sample were received by our quality team with the complaint of broken gasket.Without a sample for investigation the complaint cannot be verified and the root cause remains unknown.This complaint was forwarded to the manufacturer (flex) for further investigation into production records.With respect to the dhr review process, the result showed there were no issues reported like package damaged / defective / other during the manufacturing process.A review of the ncmr¿s was performed; the result showed there were no issues reported like package damaged / defective / other for the same part number (305602) throughout the last twelve months.
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: package damaged.

• 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: 13526371
• Report Number: 2243072-2022-00199
• Device Sequence Number: 5311610
• Product Code: FMI
• UDI-Device Identifier: 00382903056026
• UDI-Public: 00382903056026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,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: 305602
• Device Catalogue Number: 305602
• Device Lot Number: SEE SECTION H10
• 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: 01/18/2022
• Supplement Date Received by Manufacturer: 03/08/2022; Not provided
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/21/2022; 03/20/2025
• 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