MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV WINGED CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381312

Device Problem Leak/Splash (1354)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/24/2022

Event Type  malfunction  

Manufacturer Narrative

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 insyte¿ iv winged catheter leaked during the infusion.The following information was provided by the initial reporter, translated from chinese: "the patient came to our hospital for treatment due to "acute heart failure" on (b)(6) 2022.At 16:56 on (b)(6) 2022, the doctor in our hospital prescribed ceftriaxone sodium for injection for skin test, and after the test, sodium oxide injection, deacetyllanatoside injection and furosemide injection were prescribed for intravenous injection , and then prescribe 100ml sodium chloride injection with an indwelling needle for intravenous infusion.During the intravenous infusion, it was found that the needle tail leaked".

Event Description

It was reported that the bd insyte¿ iv winged catheter leaked during the infusion.The following information was provided by the initial reporter, translated from chinese: "the patient came to our hospital for treatment due to "acute heart failure" on (b)(6) 2022.At 16:56 on (b)(6)2022, the doctor in our hospital prescribed ceftriaxone sodium for injection for skin test, and after the test, sodium oxide injection, deacetyllanatoside injection and furosemide injection were prescribed for intravenous injection , and then prescribe 100ml sodium chloride injection with an indwelling needle for intravenous infusion.During the intravenous infusion, it was found that the needle tail leaked".

Manufacturer Narrative

H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD INSYTE¿ IV WINGED 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 ; 8015296192
• MDR Report Key: 16237337
• MDR Text Key: 309076157
• Report Number: 8041187-2023-00014
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903813124
• UDI-Public: 00382903813124
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151698
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381312
• Device Lot Number: 9279951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2019
• 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