MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 27X1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305109
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305109 batch#: 2279773, 1273599 it was reported by customer that we're noticing some issues with the pd 27g x1/2 needles we have in clinic.They seem to be clogging and i've been told it's happening with several boxes.Sample location: (b)(6).Verbatim: we would like to report a product defect/complaint.Please process credit or an rma for this product for your investigation.Kindly reference customer¿s # and cardinal cif on all emails and correspondence.Customer reference: (b)(6).Cardinal po: 4531395379 item: 305109 customer po: 0000222574 lot#: ref 305109 lot: 2279773 and ref 305109 lot: 1273599 case intake form submitted thru cardinal: (b)(6).Initial reporter: (b)(6).Description as reported: we're noticing some issues with the pd 27g x1/2 needles we have in clinic.They seem to be clogging and i've been told it's happening with several boxes.Sample location: (b)(6).For questions about the sample, here¿s the contact details of the customer.(b)(6).For information regarding credit to cardinal po, please reply to this email only.
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f26 ¿ no health consequences or impact device problem code: a140901 - complete blockage.
Additional Manufacturer Narrative
Pr (b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 305109 and lot numbers 2279773 and 1273599.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.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.H3 other text : see h10 narrative.
Event or Problem Description
No additional information received.Material#: 305109 batch#: 2279773, 1273599.It was reported by customer that we're noticing some issues with the pd 27g x1/2 needles we have in clinic.They seem to be clogging and i've been told it's happening with several boxes.Sample location: 1048 independent ave grand junction co 81505-6175.Verbatim: we would like to report a product defect/complaint.Please process credit or an rma for this product for your investigation.Kindly reference customer¿s # and cardinal cif on all emails and correspondence.Customer reference: (b)(4).Cardinal po: 4531395379.Item: 305109.Customer po: 0000222574.Lot#: ref (b)(64) lot: 2279773 and ref (b)(4) lot: 1273599.Case intake form submitted thru cardinal: (b)(4).Initial reporter: (b)(6).Description as reported: we're noticing some issues with the pd 27g x1/2 needles we have in clinic.They seem to be clogging and i've been told it's happening with several boxes.Sample location: 1048 independent ave grand junction co 81505-6175.For questions about the sample, here¿s the contact details of the customer.(b)(6).For information regarding credit to cardinal po, please reply to this email only.

• Brand Name: NEEDLE 27X1/2 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: 18300356
• Report Number: 1911916-2023-00887
• Device Sequence Number: 3177029
• Product Code: FMI
• UDI-Device Identifier: 30382903051091
• UDI-Public: (01)30382903051091
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/09/2024

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: 305109
• Device Lot Number: 1273599
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown