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	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
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.
Event or Problem Description
It was reported bd twinpak¿ dual cannula device had foreign matter.The following information was provided by the initial reporter: "it was reported by the facility representative that the needle does not pierce the top of the vial and a piece of rubber got inside the vial.We had a site that reported that it caused coring and a small piece of rubber was noted in the syringe".
Event or Problem Description
It was reported bd twinpak¿ dual cannula device had foreign matter.The following information was provided by the initial reporter: "it was reported by the facility representative that the needle does not pierce the top of the vial and a piece of rubber got inside the vial.We had a site that reported that it caused coring and a small piece of rubber was noted in the syringe".
Additional Manufacturer Narrative
H.6.Investigation: it was reported by the medical professional, the cannula does not pierce the top of the vial.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows part of a syringe with white solution in it.No other information is available from the photo.It could be possible the customer is not using the product as intended.This product is not designed to be inserted through a vial rubber stopper.A device history record review was completed for provided material number 303390, lot number 1088526.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 no physical sample analysis the symptom reported by the customer could not be confirmed.H3 other text : see h.10.

• 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
• MDR Report Key: 12393142
• Report Number: 1911916-2021-00903
• Device Sequence Number: 4377756
• Product Code: FMI
• UDI-Device Identifier: 30382903033905
• UDI-Public: 30382903033905
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/21/2021

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 Expiration Date: 04/30/2026
• Device Model Number: 303390
• Device Catalogue Number: 303390
• Device Lot Number: 1088526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1