MAUDE Adverse Event Report: BECTON DICKINSON BD¿ GRAVITY INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number CS42522E-07

Device Problem Component Missing (2306)

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

Event Date 01/24/2023

Event Type  malfunction  

Event Description

It was reported that 3 bd¿ gravity infusion sets were missing their white injector ports.The following information was provided by the initial reporter: "three sets of bd gravity iv sets were found on (b)(6) 2023 to be missing the white injector port where there are 3 in a row.".

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Medical 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

One sample of cs42522e-07 was submitted for quality investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample submitted shows that it is missing one of the smartsites on the three-port stopcock.A device history record review for model cs42522e-07 lot number 22119161 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue in this complaint is that the smartsite was not assembled onto to the set at the manufacturing facility.An investigation of the failure at the manufacturing facility indicates that the cause for the missing smartsite was due to the assembler not installing the smartsite during the infusion set assembly.A quality notification has been created in order correct the issue.

Event Description

It was reported that 3 bd¿ gravity infusion sets were missing their white injector ports.The following information was provided by the initial reporter: "three sets of bd gravity iv sets were found on (b)(6) to be missing the white injector port where there are 3 in a row.".

• Brand Name: BD¿ GRAVITY INFUSION SET
• 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: 16403154
• MDR Text Key: 310091869
• Report Number: 2243072-2023-00246
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CS42522E-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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