MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ VENTED VIAL ADAPTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MV0420-0006

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is yukon.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the luer-lok collar on the bd smartsite¿ vented vial adaptor broke off during use.The following information was provided by the initial reporter, translated from german: "when piercing, a piece of the adapter broke off at the side.According to the customer, the adapter was just pierced with a fine twisting motion.No patient injury.No treatment required.No user injury.No treatment required.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 02aug2022.H6: investigation summary.One mv0420-0006 sample from lot 212049 was received without packaging for investigation attached to an empty medication vial (appendix 1).The customer has confirmed that the damage to the device occurred following attempted clinical use.A visual inspection of the sample confirmed the customer experience, as part of a section of the vial access device which included one of the connecting tabs had snapped off (appendix 2).The details of this feedback were shared with the legal manufacturer of the product, yukon medical llc, for investigation.This type of damage is likely to have occurred as a result of the component being subjected to a an external force, which caused the component to become fractured; however a definitive root cause for this external force could not be determined in this instance.A review of the production records for lot 212049 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mv0420-0006 product in the past 12 months.

Event Description

It was reported that the luer-lok collar on the bd smartsite¿ vented vial adaptor broke off during use.The following information was provided by the initial reporter, translated from german: "when piercing, a piece of the adapter broke off at the side.According to the customer, the adapter was just pierced with a fine twisting motion.No patient injury, no treatment required, no user injury, no treatment required.".

• Brand Name: BD SMARTSITE¿ VENTED VIAL ADAPTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15135769
• MDR Text Key: 304621661
• Report Number: 2243072-2022-01025
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

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
• Device Operator: Other
• Device Catalogue Number: MV0420-0006
• Device Lot Number: 212049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1