MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD EXTENSION TUBING SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Defective Device (2588)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

It was reported while using unspecified bd extension tubing set the tubing was damaged and leaked.There was no report of patient impact.The following information was provided by the initial reporter: bd extension set issue.Leaking drug between the connection of the bd smartsite extension set and the icu medical microclave connector.

Manufacturer Narrative

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 (b)(4) has been listed in event date, mfr site, and the (b)(4) fda registration number has been used for the manufacture report number.Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using unspecified bd extension tubing set the tubing was damaged and leaked.There was no report of patient impact.The following information was provided by the initial reporter: bd extension set issue.Leaking drug between the connection of the bd smartsite extension set and the icu medical microclave connector.

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint of tubing defective/damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model 20043e lot number 22095286 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: UNSPECIFIED BD EXTENSION TUBING 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: 15921305
• MDR Text Key: 308157031
• Report Number: 2243072-2022-02097
• 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
• Report Date: 12/20/2022

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/06/2023
• 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