MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 21X2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305129
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a "bug" was observed stuck to the needle 21x2 rb before use after it had been opened from its packaging.The following information was provided by the initial reporter: "per customer, one of the nurse¿s opened a sterile bd precision glide needle and what appears to be a bug stuck to the needle.".
Additional Manufacturer Narrative
H.6.Investigation summary: one sample was received from the customer for investigation.The sample was visually examined and it was observed that there was a piece of black foreign matter (fm) loose in the needle shield.The needle was removed and the fm was visually examined using 30x magnification and was visually identified as a piece of burnt plastic.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.During the shielding process the black foreign matter was introduced to either the needle assembly or the shield.Bd acknowledges that the returned sample contained black foreign matter which was loose in the needle shield.However, as this occurrence would not exceed the acceptable quality level (aql) for the batch no corrective or preventative action will be taken in the scope of this complaint.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that a "bug" was observed stuck to the needle 21x2 rb before use after it had been opened from its packaging.The following information was provided by the initial reporter: "per customer, one of the nurse¿s opened a sterile bd precision glide needle and what appears to be a bug stuck to the needle.".

• Brand Name: NEEDLE 21X2 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: 8966303
• Report Number: 1911916-2019-00914
• Device Sequence Number: 10818178
• Product Code: FMI
• UDI-Device Identifier: 30382903051299
• UDI-Public: 30382903051299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: 305129
• Device Lot Number: 8361977
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other