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	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# (b)(4) batch# 3299631 it was reported by customer that the pharmacy technicians found black particles in the sterile package.Verbatim: rcc received a complaint via phone.Pir attached product complaint - customer called to report that one of the pharmacy technicians found black particles in the sterile package of the 18 g x 1 in bd precisionglide¿ needle - 305195 lot 3299631, there are several needles in the package with this issue through out the pharmacy and the lot in stock has been sequestered.Sample is available, no pt harm, date of event (b)(6) 2024.
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.H3 other text : see h10 manufacture narrative.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported black particles were found in the sterile package.To aid in the investigation, five samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed.One packaging blister has a dark colored particle that is 1/64" in size.No other defects or imperfections were observed.This defect could occur if, after a repair or preventative maintenance to the packaging equipment, cleaning was not effective inducing the foreign matter in the blister.A device history record review was completed for provided material number 305195, lot 3299631.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.Verification of the packaging process was performed, and no foreign matter of any kind was observed.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.
Event or Problem Description
No additional information received: material# 305195 batch# 3299631 it was reported by customer that the pharmacy technicians found black particles in the sterile package.Verbatim: rcc received a complaint via phone.Pir attached.Productcomplaint - customer called to report that one of the pharmacy technicians found black particles in the sterile package of the 18 g x 1 in bd precisionglide¿ needle - 305195 lot 3299631, there are several needles in the package with this issue through out the pharmacy and the lot in stock has been sequestered.Sample is available, no pt harm, date of event 04/01/2024.

• 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: 19050202
• Report Number: 1911916-2024-00239
• Device Sequence Number: 15594897
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/18/2024

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: 3299631
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown