MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD® NEEDLE 1 IN. SINGLE USE, STERILE, 25 G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305125
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 while using bd® needle 1 in.Single use, sterile, 25 g there was a mix of product in the box.There was no report of patient impact.The following information was provided by the initial reporter: a couple of needles are 5/8 are mixed in with 1 in.2 are labeled as the 1 in and 2 are labeled as the 5/8 in the 1 in box.
Additional Manufacturer Narrative
H6: investigation summary a device history record review was completed by our quality engineer team for provided material number 305125 and lot number 2117120.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h10.
Event or Problem Description
It was reported while using bd® needle 1 in.Single use, sterile, 25 g there was a mix of product in the box.There was no report of patient impact.The following information was provided by the initial reporter: a couple of needles are 5/8 are mixed in with 1 in.2 are labeled as the 1 in and 2 are labeled as the 5/8 in the 1 in box.

• Brand Name: BD® NEEDLE 1 IN. SINGLE USE, STERILE, 25 G
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17840368
• Report Number: 1911916-2023-00706
• Device Sequence Number: 17865020
• Product Code: FMI
• UDI-Device Identifier: 30382903051251
• UDI-Public: (01)30382903051251
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 10/19/2023

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 Catalogue Number: 305125
• Device Lot Number: 2117120
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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