MAUDE Adverse Event Report: BECTON DICKINSON CANNULA BLUNT PLASTIC; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303345
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 303345 batch # unknown.It was reported by customer that the tips of the blunt plastic cannula breaking off as well as issues with the vial stoppers being pushed into the vial.Verbatim: rcc received a complaint via phone.Sales rep states she is meeting with (b)(6) system.The pharmacy there is having issues with the bd interlink blunt plastic cannula ref 303345.They are having issues with the tips of the blunt plastic cannula breaking off as well as issues with the vial stoppers being pushed into the vial.Rep states they did inform her they are inserting the cannula at an angle rather than 90 degrees.Rep looking for any educational material, ifu, or information on how they should be using this product.
Additional Manufacturer Narrative
Pr (b)(4) follow up: it was reported the tips of the blunt plastic cannula are breaking off as well as the vial stoppers are being pushed into the vial.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a cannula assembled to a syringe with no plastic shield.The plastic needle is bent and damaged in the area where the tip joins the hub.No other defects or imperfections were observed.As the lot provided is 'unknown,' a device history record review could not be performed.Without the actual physical sample analysis, a probable root cause could not be offered.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
Additional information received.Did the reported issue have any impact on the patient? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? there was no reported patient impact.The hospital did report having to open multiple vials of medication due to the tip of the canula pushing the sealed vial surface into the medication.This caused them to be concerned about debris in the medication that could have been delivered but no adverse patient events were reported.Just delays in procedure time and additional supplies needed to complete patient care.Material # 303345; batch # unknown.It was reported by customer that the tips of the blunt plastic cannula breaking off as well as issues with the vial stoppers being pushed into the vial.Verbatim: rcc received a complaint via phone.Pir attached.Sales rep states she is meeting with university of washington system.The pharmacy there is having issues with the bd interlink blunt plastic cannula ref 303345.They are having issues with the tips of the blunt plastic cannula breaking off as well as issues with the vial stoppers being pushed into the vial.Rep states they did inform her they are inserting the cannula at an angle rather than 90 degrees.Rep looking for any educational material, ifu, or information on how they should be using this product.

• Brand Name: CANNULA BLUNT PLASTIC
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19837904
• Report Number: 1911916-2024-00545
• Device Sequence Number: 7816061
• Product Code: FMI
• UDI-Device Identifier: 00382903033454
• UDI-Public: (01)00382903033454
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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: Health Professional
• Device Catalogue Number: 303345
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown