MAUDE Adverse Event Report: BECTON DICKINSON BD SMARTSITE¿ NEEDLE-FREE VALVE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 5000R

Device Problems Defective Component (2292); Material Protrusion/Extrusion (2979); Packaging Problem (3007)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

It was reported that several bd smartsite¿ needle-free valves had various issues, including one from lot 17094151 that had molding defects on the end of it, one set from lot 20114303 that was missing a component, and lots 20038532 and 20098843 having different products mixed in with the bags of smartsites.The following information was provided by the initial reporter: "flashes in the valved end of smartsite, lot: 17094151"."mixed female luer cones that create stops of the machine, lot: 20038532"."during production assembly machines go in alarm and stop due to the presence of mixed products present in the bags of smartsite, lot: 20098843"."incomplete smartsites, lot: 20114303".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) 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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 17094151; medical device expiration date: na; device manufacture date: 2017-09-18.Medical device lot #: 20038532; medical device expiration date: na; device manufacture date: 2020-03-04.Medical device lot #: 20098843; medical device expiration date: na; device manufacture date: 2020-09-11.Medical device lot #: 20114303; medical device expiration date: na; device manufacture date: 2020-11-20.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: it was reported by the customer that there was an incomplete smartsite, 1 piece of the lot 20114303.Once the investigation was performed, the potential root cause was found related to a bad segregation of the defective and good material in the combo #3 machine.A device history review was conducted for lot number 20114303 built on november 10, 12 & 17, 2020 and no maintenance orders were reported in this machine related to misassemble.Pictures were received from the customer with mix product and different components were observed confirming the mixing failure mode.Since it was considered to a possible incorrect segregation during the line clearance process when the remaining material is moved back to their respecting bags, putted back to the warehouse, and pull it by automation to complete a 5000r lot.It was reported by the customer that has been received pieces with deformed/ bent luer cones.Through the (b)(4), it was found that the root cause for the failure mode bent/deformed component is a damaged core pin that causes a lack of seal resulting in flashing on ss fla, thick wall p/n: tc10011004.A device history review was conducted for lot numbers 17094151, 20038532, 20098843, and 20114303.No additional quality notes were found.

Event Description

It was reported that several bd smartsite¿ needle-free valves had various issues, including one from lot 17094151 that had molding defects on the end of it, one set from lot 20114303 that was missing a component, and lots 20038532 and 20098843 having different products mixed in with the bags of smartsites.The following information was provided by the initial reporter: "3.Flashes in the valved end of smartsite lot: 17094151" "4.Mixed female luer cones that create stops of the machine lot: 20038532" "6.During production assembly machines go in alarm and stop due to the presence of mixed products present in the bags of smartsite lot: 20098843" "7.Incomplete smartsites lot: 20114303".

• Brand Name: BD SMARTSITE¿ NEEDLE-FREE VALVE
• 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: 13534418
• MDR Text Key: 287833606
• Report Number: 2243072-2022-00209
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5000R
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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