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

Catalog Number	302890
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1046778.Medical device expiration date: na.Device manufacture date: 15-feb-2021.Medical device lot #: 0015339.Medical device expiration date: na.Device manufacture date: 15-jan-2020.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 the bd clear hub needle experienced foreign matter within the fluid path.The following information was provided by the initial reporter: customer found some attached foreign matters in the epoxy portion.
Additional Manufacturer Narrative
H6: investigation summary it was reported there was some attached foreign matters in the epoxy.To aid in the investigation, seven photos were provided for evaluation by our quality team.The photos are in high magnification and show a needle assembly with no plastic shield or packaging blister.There is foreign matter adhered to the epoxy.No other defects or imperfections were observed.A device history record review was completed for provided material number (b)(4), lot numbers 1046778 and 0015339.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.To date, there have been no other similar events reported for these lots.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.
Event or Problem Description
It was reported that the bd clear hub needle experienced foreign matter within the fluid path.The following information was provided by the initial reporter: customer found some attached foreign matters in the epoxy portion.

• Brand Name: BD CLEAR HUB 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: 15090039
• Report Number: 1911916-2022-00368
• Device Sequence Number: 17405605
• Product Code: FMI
• UDI-Device Identifier: 00382903028900
• UDI-Public: 00382903028900
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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 Catalogue Number: 302890
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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