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

Model Number	305142
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	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at least one bd eclipse needle experienced foreign matter on the device cannula.The following information was provided by the initial reporter: they have found a few with paper in the bevel.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter email: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-27.H6: investigation summary it was reported the needles looked to be barbed and has foreign matter.To aid in the investigation, eight samples with the plastic shield, but no packaging blister, and one photo was provided for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens.One sample has no defects or imperfections, the other seven samples have the tip bent, like a hook.This type of hook is created when removing the plastic shield if it is not done correctly.No other defects or imperfections were observed on these seven samples.The photo provided shows a needle assembly with no packaging blister or plastic shield.Close to the needle tip there is a white material.From the photo, it is not clear what this material is.A device history record review was completed for provided material number 305142, lot 0252741.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 photo sample analysis the symptom reported by the customer is confirmed, but a probable root cause could not be offered.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h10.
Event or Problem Description
It was reported that at least one bd eclipse needle experienced foreign matter on the device cannula.The following information was provided by the initial reporter: they have found a few with paper in the bevel.

• Brand Name: BD ECLIPSE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13314299
• Report Number: 1911916-2022-00013
• Device Sequence Number: 1463183
• Product Code: FMI
• UDI-Device Identifier: 30382903051428
• UDI-Public: 30382903051428
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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 Expiration Date: 09/30/2025
• Device Model Number: 305142
• Device Catalogue Number: 305142
• Device Lot Number: 0252741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown