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

Catalog Number	302891
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8138753, medical device expiration date: na, device manufacture date: 2018-05-18.Medical device lot #: 7285987, medical device expiration date: na, device manufacture date: 2017-10-12.(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle 27ga 7/8in ecg blt had foreign matter on the needle before use.
Additional Manufacturer Narrative
Sixteen needles were returned for evaluation.Eight were in their original shields.Eight had been crimped and bent, and had a different shield.A visual inspection of the 16 returned samples showed what appears to lube gels on the needles that had been bent.One needle had a small metal flake in the shield.The needles returned in their original shields appeared ¿cleaner¿.One of the original shield needles did have a small, dark fiber on the cannula, but no lube gels were presents.The lube does not appear to be any heavier or thicker than what is normally applied.Lubed needles, if they are not shielded, will pick up fm from being handled as well as from the environment.The needles returned in the original shields do not appear to have fm, and are within specification limits.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.A device history record review was completed.Batch 7285987 had 11 visual inspections performed on 700 parts with zero defects noted.Cleaning was performed twice during the assembly of this batch.Batch 8138753 had 23 visual inspections performed on 1,300 parts with zero defects noted.Cleaning was performed three times during the assembly of this batch.No quality notifications were written for this batch, nor for the associated assembly batch.
Event or Problem Description
It was reported that bd needle 27ga 7/8in ecg blt had foreign matter on the needle before use.

• Brand Name: BD 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: 8092246
• Report Number: 1911916-2018-00682
• Device Sequence Number: 13997801
• Product Code: FMI
• UDI-Device Identifier: 50382903028912
• UDI-Public: 50382903028912
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/05/2018

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: Other
• Device Catalogue Number: 302891
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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