MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305125
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mat# 305125, batch# 2117120.It was reported by the customer that bd sku# 305125 is supposed to be a 25g x 1" hypodermic needle.However, the customer discovered multiple instances of roughly 1/2" needles mixed in amongst 2 boxes of 100.They sent pictures and have retained samples to send back for inspection.Please make arrangements to send a prepaid return kit to the address below.
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a0201 - product quality problem.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation: it was reported 1/2" needles were mixed in with 25g x 1" hypodermic needles.To aid in the investigation, one hundred eighty-eight samples in sealed packaging blisters and three photos were received for evaluation by our quality team.A visual inspection was performed, and twenty-three samples were 25g x 1/2".The three photos provided show some of the sample received.No other defects or imperfections were observed.This defect could occur if line clearance was not performed effectively.A device history record review was completed for provided material number: 305125, lot: 2117120.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.The samples will be shown to associates for awareness.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
(b)(4) additional information received mat# 305125 batch# 2117120 it was reported by the customer that bd sku# 305125 is supposed to be a 25g x 1" hypodermic needle.However, the customer discovered multiple instances of roughly 1/2" needles mixed in amongst 2 boxes of 100.Verbatim: complaint received via email.Email(s) attached.Bd sku# 305125 is supposed to be a 25g x 1" hypodermic needle.However, the customer discovered multiple instances of roughly 1/2" needles mixed in amongst 2 boxes of 100.They sent pictures and have retained samples to send back for inspection.Please make arrangements to send a prepaid return kit to the address below.--------------- add info received ¿ the date you discovered this issue? 10/27/2023 ¿ how many mis-marked needles did you document? 2 boxes of 100 mixed with 1¿ and ½¿ marked as 1¿.¿ was there any impact to patients and/or staff? not to my knowledge ¿ do you still have the affected samples in your possession to return to bd for inspection? on its way to xxx.

• Brand Name: NEEDLE 25X1 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18118445
• Report Number: 1911916-2023-00839
• Device Sequence Number: 20551744
• Product Code: FMI
• UDI-Device Identifier: 30382903051251
• UDI-Public: (01)30382903051251
• 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): 11/16/2023

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: 305125
• Device Lot Number: 2117120
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown