MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 22X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305155
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	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a device history record review was completed for provided material number 305155 and lot number 9162963.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one physical sample and three photos were received for evaluation by our quality team.The sample came in an opened packaging blister.A visual inspection was performed and there is a small white foam ball at the needle tip.No other defects or imperfections were observed.The three photos provided show the sample received.It could be possible for this defect to occur if the foam used to protect the needle tip during the final inspection induced the white foam ball at the needle tip.Based on the investigation with the returned sample and photo sample analysis the symptom reported by the customer is confirmed.Further action has not been determined necessary at this time.".
Event or Problem Description
It was reported that a needle 22x1 rb had foreign matter during use.The following was reported by the initial reporter: "it was reported that there is a small styrofoam ball in the bevel tip.Verbatim: per customer's response: (b)(6) 2021.Event date (b)(6) 2021.No one hurt.Opened a new bd precisionglide needle 22g x 1 lot# 9162963 and when uncapping the needle found what appears to be a small styrofoam ball in the bevel tip.".

• Brand Name: NEEDLE 22X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11417969
• Report Number: 1911916-2021-00179
• Device Sequence Number: 17258516
• Product Code: FMI
• UDI-Device Identifier: 30382903051558
• UDI-Public: 30382903051558
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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 Expiration Date: 08/31/2024
• Device Model Number: 305155
• Device Catalogue Number: 305155
• Device Lot Number: 9162963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1