MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305195
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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#: (b)(4) batch#: unknown it was reported by customer that description of complaint: this syringe came out of the package/box in this format (see picture below) and cut my sonographer.Staff member was poked, no patient involvement.Staff member filled out an incident report indicating ¿needle stick injury ¿ from incorrect packaging¿.In his report he indicates applying an 18g bd precision glide needle to a syringe for making ¿flushes¿ when he was poked.The needle was poking out through the plastic cover and wrapper.Punctured his finger causing bleeding for 5-10 minutes.Verbatim: rcc received a complaint via email.Email(s) attached.Description of complaint: this syringe came out of the package/box in this format (see picture below) and cut my sonographer.Staff member was poked, no patient involvement.Staff member filled out an incident report indicating ¿needle stick injury ¿ from incorrect packaging¿.In his report he indicates applying an 18g bd precision glide needle to a syringe for making ¿flushes¿ when he was poked.The needle was poking out through the plastic cover and wrapper.Punctured his finger causing bleeding for 5-10 minutes.¿ are you able to provide the date of the event? (b)(6) 2024 ¿ did you experience any adverse events as a result of this reported defect? no ¿ was there any patient impact or patient involvement?no ¿ are samples available for investigation/evaluation? if so, please provide/confirm your mailing address and let me know if you need a canister for safe sample management.This was discarded in the sharps container so it did not involve any other injuries.¿ if no products are able to be sent, if possible, please provide picture/video of issue? no video- i have picture attached our reference number: (b)(4) date reported: 01-22-2024.
Additional Manufacturer Narrative
(b)(4).Follow up.It was reported the needle was poking out through the plastic cover and wrapper.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a needle assembly connected to a syringe.The needle assembly is passing through the shield.No other defects or imperfections were observed.The condition of the needle assembly is not in the condition it leaves the manufacturing site.The needle is shipped out in a packaging blister and not connected to a syringe.A device history record review was completed for provided material number 305195, lot 3158795.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
Additional information received.Material#: 305195.Batch#: unknown.It was reported by customer that description of complaint: this syringe came out of the package/box in this format (see picture below) and cut my sonographer.Staff member was poked, no patient involvement.Staff member filled out an incident report indicating ¿needle stick injury ¿ from incorrect packaging¿.In his report he indicates applying an 18g bd precision glide needle to a syringe for making ¿flushes¿ when he was poked.The needle was poking out through the plastic cover and wrapper.Punctured his finger causing bleeding for 5-10 minutes.Verbatim: rcc received a complaint via email.Email(s) attached.Description of complaint: this syringe came out of the package/box in this format (see picture below) and cut my sonographer.Staff member was poked, no patient involvement.Staff member filled out an incident report indicating ¿needle stick injury ¿ from incorrect packaging¿.In his report he indicates applying an 18g bd precision glide needle to a syringe for making ¿flushes¿ when he was poked.The needle was poking out through the plastic cover and wrapper.Punctured his finger causing bleeding for 5-10 minutes.¿ are you able to provide the date of the event? january 22, 2024.¿ did you experience any adverse events as a result of this reported defect? no.¿ was there any patient impact or patient involvement? no.¿ are samples available for investigation/evaluation? if so, please provide/confirm your mailing address and let me know if you need a canister for safe sample management.This was discarded in the sharps container so it did not involve any other injuries.¿ if no products are able to be sent, if possible, please provide picture/video of issue? no video- i have picture attached.Our reference number: (b)(4).Date reported: 01-22-2024.Follow-up: customer response on february 26, 2024: 1) it poked a sonographer, bleeding occurred for 10 minutes, no adverse reaction thereafter.2) other than washing, treating and covering ¿ holding up his patient for testing was the only delay.3) i shared a photo of the needle in my original email and have attached it as well.4) affected staff, no patient incident ¿ his needle stick injury healed without complications.5) we treated at time of by washing, applying ointment and covering.No further treatment was required.6) staff member has had no complications and finger healed since incident.7) picture above attached.

• Brand Name: NEEDLE 18X1 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18698255
• Report Number: 1911916-2024-00094
• Device Sequence Number: 7271571
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

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: 305195
• Device Lot Number: 3158795
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown