MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
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
Material# 305197 batch# 3320201 it was reported by customer that one needle with a bent tip, and two broken/cracked needles verbatim rcc received a complaint via email.Email(s) attached.The customer reported that they received a bad batch/lot of needles.From that box they had one needle with a bent tip, and two broken/cracked needles.The customer advised they discarded the impacted box/lot after opening and discovering this issue immediately (the needles were not used on patients, the defects were discovered upon opening the box.The customer advised they have two unopened boxes of the same lot# that can be returned to evaluate, however the original box with the defects was discarded.Product#: 305197.Lot#: 3320201.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported there was one needle with a bent tip and two broken needles.To aid in the investigation, six hundred samples in sealed packaging blisters and one photo was provided for evaluation by our quality team.Eighty samples were randomly selected for investigation.A visual inspection was performed with a 30x microscope.There was no damaged, defective grind or hooks observed.The bevels and etch were good.No damage of any kind was observed to the needle hubs.The photo provided shows a needle assembly with no packaging blister or plastic shield.The needle hub is damaged.No other defects or imperfections were observed.A device history record review was completed for provided material number 305197, lot 3320201.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.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed but is confirmed with the photo analysis.Without the actual defective physical sample, a probable root cause could not be offered.
Event or Problem Description
No additional information received.Material# 305197.Batch# 3320201.It was reported by customer that one needle with a bent tip, and two broken/cracked needles.Verbatim.Rcc received a complaint via email.Email(s) attached.The customer reported that they received a bad batch/lot of needles.From that box they had one needle with a bent tip, and two broken/cracked needles.The customer advised they discarded the impacted box/lot after opening and discovering this issue immediately (the needles were not used on patients, the defects were discovered upon opening the box.The customer advised they have two unopened boxes of the same lot# that can be returned to evaluate, however the original box with the defects was discarded.Product#: 305197.Lot#: 3320201.

• Brand Name: NEEDLE 16X1 RB
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 19390646
• Report Number: 1911916-2024-00375
• Device Sequence Number: 7753656
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/14/2024

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: 305197
• Device Lot Number: 3320201
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown