MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 23X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305145
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a0205 - packaging problem (3007).
Event or Problem Description
Mat#: 305145 batch#: 2299263.It was reported by customer that they found an incorrect needle in with the 23gx1¿ precision glide needle.Lot: 2299263 exp: 12-31-2027.Verbatim: rcc received complaint via email.Email(s) attached.We found an incorrect needle in with the 23gx1¿ precision glide needle.Lot: 2299263 exp: 12-31-2027.17oct2023.¿ date of event: 09/06/2023.¿ event was noted before use on patient.¿ no change or delay in treatment.¿ preparing anaphylaxis kits to send to the home for patients ¿ yes sample is available : xxx.
Additional Manufacturer Narrative
(b)(4) - follow up for device evaluation it was reported an incorrect needle was mixed in.To aid in the investigation, a strip of five sealed packaging blisters and two photos were received for evaluation by our quality team.A visual inspection was performed, and one of the packaging blisters has a different needle assembly.The two photos provided show the samples received.No other defects or imperfections were observed/ this defect could occur if, during line clearance, the unit was not detected.A device history record review was completed for provided material number (b)(4), lot 2299263.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 sample will be shown to associates for awareness.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 mat#: (b)(4) batch#: 2299263 it was reported by customer that they found an incorrect needle in with the 23gx1¿ precision glide needle.Lot: 2299263 exp: 12-31-2027.Verbatim: rcc received complaint via email.Email(s) attached.We found an incorrect needle in with the 23gx1¿ precision glide needle.Lot: 2299263 exp: 12-31-2027 17oct2023 ¿ date of event: (b)(6) 2023 ¿ event was noted before use on patient ¿ no change or delay in treatment ¿ preparing anaphylaxis kits to send to the home for patients ¿ yes sample is available : xxx.

• Brand Name: NEEDLE 23X1 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: 17984440
• Report Number: 1911916-2023-00793
• Device Sequence Number: 8171720
• Product Code: FMI
• UDI-Device Identifier: 30382903051459
• UDI-Public: (01)30382903051459
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 10/30/2023

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: 305145
• Device Lot Number: 2299263
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown