MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 27GA 7/8IN ECG BLT; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	302891
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	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.Investigation summary: it was reported that a black foreign body was released from the cannula.To aid in the investigation, one video was provided for evaluation by our quality team.The video shows a needle going through what appears a transparent bubble.Then, inside of it, a solution is expelled creating black bubbles.A device history record review was completed for provided material number 302891, lot number 9149539.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.The last three years of complaints for this product were reviewed and this is the first complaint for this and similar defects.Based on the investigation and with the video sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis, a probable root cause could not be offered.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 27ga 7/8in ecg blt had a loose, black thread on it during surgery.The following information was provided by the initial reporter: "during a surgery the cannula loose a foreign body (black thread shape).".

• Brand Name: NEEDLE 27GA 7/8IN ECG BLT
• 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: 12442966
• Report Number: 1911916-2021-00956
• Device Sequence Number: 3891179
• Product Code: FMI
• UDI-Device Identifier: 50382903028912
• UDI-Public: 50382903028912
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: Other
• Device Model Number: 302891
• Device Catalogue Number: 302891
• Device Lot Number: 9149539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1