MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30X1 RB; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305128
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
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.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material# :305128, lot#:3024960.It was reported by the customer that they have clogged needles and unable to inject to patient verbatim: rcc received a complaint via email.Email(s) attached.Compliant created 2nd customer: we have had complaints from 2 customers regarding the 305128 ¿ 30g x 1¿ hypo needles ¿ lot 3024960 some of the needles were clogged and not able to inject the patient.No stock left to send back for investigation.No injuries reported to patients.Additional info received on 20-feb-2024.Does both customers belong to same user facility? if different, please provide details, no they are different facilities what are the date of events for both customers? 2/1/2024 and 2/5/2024 do both the customers have same batch numbers? yes.Was the product received in this condition? ¿ product is received in by cipm packaged into procedural kits.They are not used until in the field at customer facilities.What is the full name and address of the facilities for where the issues occurred? west tennessee bone and joint (b)(6).Precision spine and pain management (b)(6).Was this issue discovered before injecting to patient? yes.
Additional Manufacturer Narrative
Pr (b)(4) follow up a device history record review was completed by our quality engineer team for provided material number 305128 and lot number 3024960.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.
Event or Problem Description
Additional information received material# : 305128 lot#: 3024960 it was reported by the customer that they have clogged needles and unable to inject to patient verbatim: rcc received a complaint via email.Email(s) attached.Compliant created 2nd customer: (b)(6).We have had complaints from 2 customers regarding the 305128 ¿ 30g x 1¿ hypo needles ¿ lot 3024960 some of the needles were clogged and not able to inject the patient.No stock left to send back for investigation.No injuries reported to patients.Additional info received on 20-feb-2024 ¿does both customers belong to same user facility? if different, please provide details ¿ no they are different facilities ¿what are the date of events for both customers? 2/1/2024 and 2/5/2024 ¿do both the customers have same batch numbers? - yes ¿was the product received in this condition? ¿ product is received in by cipm packaged into procedural kits.They are not used until in the field at customer facilities.¿what is the full name and address of the facilities for where the issues occurred? (b)(6).Additional information received on 21-feb-2023 product was stored in a temperature controlled warehouse.¿was this issue discovered before injecting to patient? yes additional information received on 21-feb-2023 product was stored in a temperature controlled warehouse additional info received on 22-feb-2024 2/1/24 was west tennessee bone and joint 2/5/24 was precision spine and pain management.

• Brand Name: NEEDLE 30X1 RB
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18753313
• Report Number: 1911916-2024-00124
• Device Sequence Number: 3741149
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: 305128
• Device Lot Number: 3024960
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown