MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 21X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305165
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: (b)(4).Batch #: 2299299, 3055942.It was reported by customer that there was burring and particulates along the length of the needle.Verbatim: "we recently bought (b)(4) cases of part bd-305165: needle bd single use 21g x 1" green.We received (b)(4) cases of lot 2299299 and (b)(4) cases of 3055942.During testing the lab was seeing abnormal needle performance.Upon further internal investigation it was noticed there was burring and particulates along the length of the needle.Therefore, these are unusable.We received lot 2228051 in a prior delivery, and they are working as expected.I was wondering if it was possible to get more cases of lot 2228051 or a completely new lot delivered?".
Additional Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement.Device problem code: a180104 - device contamination with chemical or other material.Batch 3055942: manufacture date 2023-02-24.Batch 2299299: manufacture date 2028-01-31.
Additional Manufacturer Narrative
(b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 305165 and lot numbers 2299299 and 3055942.The review did not reveal any detected abnormalities during the production process that could have contributed to these defects 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.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
No additional information received material #: 305165, batch #: 2299299, 3055942.It was reported by customer that there was burring and particulates along the length of the needle.Verbatim: "we recently bought 10 cases of part bd-305165: needle bd single use 21g x 1" green.We received 7 cases of lot 2299299 and 3 cases of 3055942.During testing the lab was seeing abnormal needle performance.Upon further internal investigation it was noticed there was burring and particulates along the length of the needle.Therefore, these are unusable.We received lot 2228051 in a prior delivery, and they are working as expected.I was wondering if it was possible to get more cases of lot 2228051 or a completely new lot delivered?".

• Brand Name: NEEDLE 21X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18181970
• Report Number: 1911916-2023-00853
• Device Sequence Number: 7890302
• Product Code: FMI
• UDI-Device Identifier: 30382903051657
• UDI-Public: (01)30382903051657
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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: Health Professional
• Device Catalogue Number: 305165
• Device Lot Number: 3055942
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown