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

Catalog Number	305195
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	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305195 batch # 4150728.It was reported by customer that product has excessive residue of glue on the hub.Rcc received a complaint via email.Product 305195 has been rejected in our incoming receiving area by our quality team for the below reason: product has excessive residue of glue on the hub -see picture attached, samples available.Busse item# 8080a-1.Bd item# 305195- 18 gauge x 1" needle.Lot# 4150728.Po (b)(4).Qty rejected (b)(4).
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.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported there was excessive residue of glue on the hub.To aid in the investigation, eight samples with no packaging blisters and one photo was provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The samples were acceptable according to product specifications.The photo provided shows the samples received.A device history record review was completed for provided material number 305195, lot 4150728.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 could not be confirmed.
Event or Problem Description
Can you please provide an exact date of event in this format dd-mmm-yyyy? product was received 25/07/2024, defective product was found the same day.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.This was found on our incoming area.Therefore, it was never used in a patient.Material # 305195; batch # 4150728.It was reported by customer that product has excessive residue of glue on the hub.Rcc received a complaint via email.Email(s) attached.Product 305195 has been rejected in our incoming receiving area by our quality team for the below reason: product has excessive residue of glue on the hub.Samples available.Busse item# 8080a-1.Bd item# 305195- 18 gauge x 1" needle.Lot# 4150728.(b)(4).Qty rejected 2 cases (b)(4) pcs.

• 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: 19968302
• Report Number: 1911916-2024-00584
• Device Sequence Number: 8967124
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/20/2024

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: 4150728
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown