MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY; INTRAVASCULAR CATHETER

Catalog Number 386806

Device Problem Leak/Splash (1354)

Patient Problem Phlebitis (2004)

Event Date 07/18/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd cathena¿ safety iv catheter with bd multiguard¿ technology experienced leakage.The following information was provided by the initial reporter, translated from spanish to english: leakage at insertion side: "it is reported that after insertion of the catheter the insertion site is very dilated, which even causes the medication to leak out almost unnoticed.

Event Description

It was reported that the bd cathena¿ safety iv catheter with bd multiguard¿ technology experienced leakage.The following information was provided by the initial reporter, translated from spanish to english: leakage at insertion side: "it is reported that after insertion of the catheter the insertion site is very dilated, which even causes the medication to leak out almost unnoticed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 10-aug-2023.H6: investigation summary: our quality engineer inspected the 1 representative sample submitted for evaluation.The reported issues of leakage.The sample was found to be within manufacturing specifications.The sample also underwent leakage testing, and no leakage was observed.Bd could not determine a manufacturing related root cause since the reported defects were not confirmed during the evaluation of the sample.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17447389
• MDR Text Key: 320292240
• Report Number: 8041187-2023-00383
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K172506
• 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: 09/18/2023

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: 386806
• Device Lot Number: 2299525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 10/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• 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