MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON PRO IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 391379

Device Problem Break (1069)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: unknown 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 the bd neoflon pro iv catheter the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: after the punctuation the catheter cannot enter the vein, the small children have to be serval times punctured.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, returned to manufacturer on: 16-mar-2023.H6: investigation summary: our quality engineer inspected the 2 representative and 4 used samples submitted for evaluation.The reported issue of catheter defective / damaged was not confirmed upon inspection and testing of the samples.Analysis of the sample showed that there were no damages or abnormalities on the samples.The used samples were observed to have no defects.The representative samples underwent functional testing and passed with no defects observed.Bd cannot determine a root cause for the event reported since the defect was not confirmed in the sample evaluations.

Event Description

It was reported while using the bd neoflon pro iv catheter the catheter was damaged.There was no report of patient impact.The following information was provided by the initial reporter: after the punctuation the catheter cannot enter the vein, the small children have to be serval times punctured.

• Brand Name: BD NEOFLON PRO IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16441162
• MDR Text Key: 310350847
• Report Number: 8041187-2023-00063
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 391379
• Device Lot Number: 0205508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• 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