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

Catalog Number	303390
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
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 that the needle in the cannula twinpak device broke off and pulled out of the hub before use when the nurse removed it from the package.The following information was provided by the initial reporter: "the red end broke off as the rn took it out of the package.".
Additional Manufacturer Narrative
Investigation: one (1) sample was provided by the customer for investigation.The sample was visually examined using unaided vision and it was observed that the red needle hub had broken off with part of the needle hub still attached to the needle and the rest of the needle hub having been broken off.The part of the needle hub which had broken off was not returned by the customer.The portion of the needle hub which was still attached to the needle and had been returned was attempted to be removed from the shield and was successful removed; however, doing so further damaged the portion of the needle hub assembly which was still attached to the needle.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Based on the effort required to remove the portion of the needle hub assembly, which was still attached to the needle, from the shield it appears that the red needle hub assembly was inserted too far into the shield which caused it to be stuck in the shield.Therefore, when the customer attempted to remove the needle hub assembly from the shield the needle hub assembly was jammed in which did not allow it to be removed.The force applied by the customer attempting to remove the needle hub assembly then caused the needle hub to break.Bd acknowledges that the returned sample had a broken needle hub which was likely caused by the needle hub assembly being inserted into the cap too far which caused excessive shield removal force.
Event or Problem Description
It was reported that the needle in the cannula twinpak device broke off and pulled out of the hub before use when the nurse removed it from the package.The following information was provided by the initial reporter: "the red end broke off as the rn took it out of the package.".

• Brand Name: CANNULA TWINPAK 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: 9244877
• Report Number: 1911916-2019-01118
• Device Sequence Number: 16613935
• Product Code: FMI
• UDI-Device Identifier: 30382903033905
• UDI-Public: 30382903033905
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (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): 11/11/2019

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: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 303390
• Device Lot Number: 9058618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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