MAUDE Adverse Event Report: BECTON DICKINSON EXT STABILIZED EXTENSION SET MAXZERO; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 201-0021

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

It was reported that the end of the unspecified bd¿ ext extension set had a loose connection to the needle-free connector and detached from it.The following information was provided by the initial reporter: "customer was concerned that the end of the ext extension set (where the needle free connector is attached) can be ripped off easily.".

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and 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.Date of event: unknown.The date received by manufacturer has been used for this field.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

The following fields were updated due to additional information: describe event or problem: it was reported that the end of the ext stabilized extension set maxzero had a loose connection to the needle-free connector and detached from it.The following information was provided by the initial reporter: "customer was concerned that the end of the ext extension set (where the needle free connector is attached) can be ripped off easily." medical device brand name: ext stabilized extension set maxzero catalog # 201-0021 medical device lot #: 9451923.Medical device expiration date: 29-mar-2025.Device manufacture date: 01-jul-2022.

Event Description

It was reported that the end of the ext stabilized extension set maxzero had a loose connection to the needle-free connector and detached from it.The following information was provided by the initial reporter: "customer was concerned that the end of the ext extension set (where the needle free connector is attached) can be ripped off easily.".

Event Description

It was reported that the end of the ext stabilized extension set maxzero had a loose connection to the needle-free connector and detached from it.The following information was provided by the initial reporter: "customer was concerned that the end of the ext extension set (where the needle free connector is attached) can be ripped off easily.".

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed the extension tubing detached from the main hub of the device.The reported issue was confirmed and determined to be manufacturing related.At this time, a root cause could not be determined exactly where in the manufacturing process this occurred.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: EXT STABILIZED EXTENSION SET MAXZERO
• 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: 16359874
• MDR Text Key: 309647081
• Report Number: 2243072-2023-00189
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 05/19/2023

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: 201-0021
• Device Lot Number: 9451923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/12/2023
• Supplement Dates Manufacturer Received: 01/18/2023; 05/19/2023
• Supplement Dates FDA Received: 02/15/2023; 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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