MAUDE Adverse Event Report: BECTON DICKINSON BD¿ GRAVITY IV SET WITH 3-PORT CLOSED MANIFOLD; INTRAVASCULAR ADMINISTRATION SET

Catalog Number CM42500E-07

Device Problems Separation Failure (2547); Separation Problem (4043)

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified 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 (b)(6) has been listed and the (b)(6) 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.

Event Description

It was reported that 10 bd¿ gravity iv sets with 3-port closed manifold disconnected during use.The following information was provided by the initial reporter: "we are having issues with the new bd gravity iv w/ 3-port tubing sets, ref# (b)(4).They are disconnecting and popping off.Reported this happening with 10 patients yesterday.While speaking with the team, they mentioned they are tightening every single set they get.We didn't have this issue with our previous tubing.".

Event Description

It was reported that 10 bd¿ gravity iv sets with 3-port closed manifold disconnected during use.The following information was provided by the initial reporter: "we are having issues with the new bd gravity iv w/ 3-port tubing sets, ref# cm42500e-07.They are disconnecting and popping off.Reported this happening with 10 patients yesterday.While speaking with the team, they mentioned they are tightening every single set they get.We didn't have this issue with our previous tubing.".

Manufacturer Narrative

H.6.Investigation: one used gravity set, model cm42500e-07, was received by the customer for investigation.Upon visual inspection, it could be observed that the female luer on the manifold within the set had disconnected from its male luer connector.No other defects were observed.The customer's complaint that the tubing is disconnecting was verified.Visual inspection under magnification was performed on both the internal and external tubing engagement components.No defects were observed.When the two tubing components were manually connected, the connection appeared tight and secure.A device history record review could not be performed on model cm42500e-07 because a lot number was not provided by the customer.

• Brand Name: BD¿ GRAVITY IV SET WITH 3-PORT CLOSED MANIFOLD
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12511850
• MDR Text Key: 272679602
• Report Number: 2243072-2021-02361
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CM42500E-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2021
• 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