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

Catalog Number	305109
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Material# 305109 batch# 3179204 it was reported by customer that placed cap back on needle the needle pushed through the plastic cover, causing a needle stick to rn's thumb.Verbatim: rcc received a complaint via phone.Pir attached.When this rn placed cap back on needle the needle pushed through the plastic cover, causing a needle stick to rn's thumb.Lot number - 3179204.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Additional information received was the needle contaminated with body fluid? yes.Were there any medical interventions required for the needle stick? no.Material# 305109.Batch# 3179204.It was reported by customer that placed cap back on needle the needle pushed through the plastic cover, causing a needle stick to rn's thumb.Verbatim: rcc received a complaint via phone.Pir attached when this rn placed cap back on needle the needle pushed through the plastic cover, causing a needle stick to rn's thumb.Lot number - 3179204.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation it was reported the needle pushed through the plastic cover.To aid in the investigation, one sample with no packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed with 10x magnification.The plastic shield has a perforation 3/4" from the bottom of the plastic shield.The photo provided shows the sample received.No other defects or imperfections were observed.It could be possible the customer is not using the product as intended.The needle should not be recapped.A device history record review was completed for provided material number 301509, lot 3179204.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 returned sample analysis the symptom reported by the customer is confirmed.

• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19770614
• Report Number: 1911916-2024-00515
• Device Sequence Number: 12991982
• Product Code: FMI
• UDI-Device Identifier: 30382903051091
• UDI-Public: (01)30382903051091
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305109
• Device Lot Number: 3179204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown