MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INTIMA-II INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

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

Event Date 11/09/2021

Event Type  malfunction  

Event Description

It was reported when using the unspecified bd intima-ii, the device experienced leakage. The following information was provided by the initial reporter. The customer stated: patient went to hospital because of "paroxysmal dizziness with nausea 1 day" on november 9, intravenous fluids with venipuncturing was given by following the doctor's advice. When the responsible nurse performed the puncture to the patient, the puncture was successful and blood was drawn back. When the infusion liquid was connected, the indwelling needle was leaking from the needle handle, and the venous access was checked. The connection was tight, and there was still leaking, so the indwelling needle was removed, after the replacement of the new indwelling needle and re-puncture, the venous access was unobstructed, no fluid leakage occurred again, and no other adverse effects were caused to the patient.

Manufacturer Narrative

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. 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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received.  the lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Information will be captured on trend reports and monitored monthly.  our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: UNSPECIFIED BD INTIMA-II
• Type of Device: INTRAVASCULAR CATHETER
• 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: 12980398
• MDR Text Key: 286357197
• Report Number: 2243072-2021-02897
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2021
• 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