MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 20GA 1IN; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305175
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported that when recapping the needle in the sterile compounding room, the needle went through the cap and stuck pharmacy technician.To aid in the investigation, two samples and two photos were provided for evaluation by our quality team.One sample came in an opened packaging blister with the plastic shield.A visual inspection was performed and no defects or imperfections were observed on this sample.The other sample came with no packaging blister and has the plastic shield.1/8" of the needle is through the plastic shield and is exposed.The needle is also bent.The two photos provided show a needle assembly with the plastic shield.The needle is bent and the need tip is through the plastic shield.No other defects or imperfections are observed in the photos.This defect can occur if the product is not being used as intended.The needle assembly should not be recapped.A device history record review was completed for provided material number 305175, lot number 0301786.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.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.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the needle 20ga 1in pierced through the shield before use.The following information was provided by the initial reporter: "a pharmacy technician experienced a needlestick injury when recapping a needle in our sterile compounding room.The needle came through the side of the needle tip cover.".

• Brand Name: NEEDLE 20GA 1IN
• 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: 12263201
• Report Number: 1911916-2021-00776
• Device Sequence Number: 3635381
• Product Code: FMI
• UDI-Device Identifier: 30382903051756
• UDI-Public: 30382903051756
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2021

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: 12/31/2025
• Device Model Number: 305175
• Device Catalogue Number: 305175
• Device Lot Number: 0301786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1