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

Catalog Number	305195
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): 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.
Event or Problem Description
Material#: 305195.Batch number#: 3233736.It was reported by customer that found a 18g bd needle with odd dots all across the surface.The dots are not a part of the thin plastic packaging, but rather on the needle itself.It may possibly be ink or some other residue, but it did not seem safe or sterile to use.In conjunction with the 18g bd needle with a piece of hair imbedded into the packaging was also found a few weeks ago, it does raise questions about the current manufacturing practices with these needles.Unfortunately, the needle with the hair was not saved and the lot number was not noted.Issue occurred on (b)(6).Product was saved.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there were dots on the needle.To aid in the investigation, one sample in a sealed packaging blister was received for evaluation by our quality team.A visual inspection was performed with 10x magnification.The plastic shield has black specks of embedded degraded resin.No other defects or imperfections were observed.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.A device history record review was completed for provided material number 305195, lot 3233736.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 material#: 305195, batch number#: 3233736.It was reported by customer that found a 18g bd needle with odd dots all across the surface.The dots are not a part of the thin plastic packaging, but rather on the needle itself.It may possibly be ink or some other residue, but it did not seem safe or sterile to use.In conjunction with the 18g bd needle with a piece of hair imbedded into the packaging was also found a few weeks ago, it does raise questions about the current manufacturing practices with these needles.Verbatim#: rcc received a complaint via email.Email(s) attached.Over the weekend iv room pharmacy tech found a 18g bd needle with odd dots all across the surface.The dots are not a part of the thin plastic packaging, but rather on the needle itself.It may possibly be ink or some other residue, but it did not seem safe or sterile to use.In conjunction with the 18g bd needle with a piece of hair imbedded into the packaging was also found a few weeks ago, it does raise questions about the current manufacturing practices with these needles.I have a sample of the product in my office.Lot number is 3233736.Response: unfortunately, the needle with the hair was not saved and the lot number was not noted.Issue occurred on 3/18.Product was saved.

• 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: 19011038
• Report Number: 1911916-2024-00226
• Device Sequence Number: 11732396
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/17/2024

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: 3233736
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown