MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD TWINPAK¿ DUAL CANNULA DEVICE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303390
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd twinpak¿ dual cannula device plastic tip often cores out a piece of the rubber stopper.The following information was provided by the initial reporter: plastic tip often core out a piece of the rubber stopper.
Event or Problem Description
It was reported that the bd twinpak¿ dual cannula device plastic tip often cores out a piece of the rubber stopper.The following information was provided by the initial reporter: plastic tip often core out a piece of the rubber stopper.
Additional Manufacturer Narrative
H6: investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.A device history review could not be completed as no batch number was provided.H3 other text : see h10.

• Brand Name: BD TWINPAK¿ DUAL CANNULA DEVICE
• 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: 16109237
• Report Number: 1911916-2022-00794
• Device Sequence Number: 3167551
• Product Code: FMI
• UDI-Device Identifier: 30382903033905
• UDI-Public: (01)30382903033905
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• 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): 01/06/2023

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: 303390
• Device Catalogue Number: 303390
• Device Lot Number: UNKNOWN
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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