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

Catalog Number 5000R

Device Problem Packaging Problem (3007)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

It was reported that the bd smartsite¿ needle-free valve experienced a mix of product types in a pack.The following information was provided by the initial reporter: found one with a cap connected.

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.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 21128509.D4: medical device expiration date: na.H4: device manufacture date: 06-dec-2021.D4: medical device lot #: 21128801.D4: medical device expiration date: na.H4: device manufacture date: 09-dec-2021.D4: medical device lot #: 211288012.D4: medical device expiration date: na.H4: device manufacture date: 09-dec-2021.H6: investigation summary: pictures were received from the customer with mix product and different components were observed confirming the mixing failure mode, a gemba walk, and revision of the process was conducted in automation and final assembly lines, since no trend was found in a year related to this failure mode on this model, the potential causes were defined as: incorrect material returned and incorrect segregation.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.A device history review was conducted for lot number 21128509.

Event Description

It was reported that the bd smartsite¿ needle-free valve experienced a mix of product types in a pack.The following information was provided by the initial reporter: found one with a cap connected.

• 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: 14497230
• MDR Text Key: 293167754
• Report Number: 2243072-2022-00730
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061285
• 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: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5000R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2022
• 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