MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number 381212

Device Problem Leak/Splash (1354)

Patient Problem Tissue Damage (2104)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use of the insyte yel 24ga x 0.75in there was a problem with leakage at the extender.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: i inform you that we have encountered quality incidents with the catheter reference 381212 in our 2 pediatric departments: in emergencies: an isolated case where the mandrel which perforated the catheter, it was set aside if necessary.Problems of leakage with the extender were also reported to me.In pediatric department, difficulties related to either the dressing or the catheter or the set up, which resulted in skin lesion on children's hands.So we are wondering about all aspects of this problem: so could you tell me if a technical change has been made to our reference 381212.I thank you for getting closer to the technical nurse, who meets this difficulty.

Manufacturer Narrative

Investigation summary: our quality engineer inspected the returned photos but could not clearly identify the reported defects.Since no batch number or samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported that during use of the insyte yel 24ga x 0.75in there was a problem with leakage at the extender.Foreign complaint the following information was provided by the initial reporter, translated from french to english: i inform you that we have encountered quality incidents with the catheter reference 381212 in our 2 pediatric departments: in emergencies: an isolated case where the mandrel which perforated the catheter, it was set aside if necessary.Problems of leakage with the extender were also reported to me.In pediatric department, difficulties related to either the dressing or the catheter or the set up, which resulted in skin lesion on children's hands.So we are wondering about all aspects of this problem: so could you tell me if a technical change has been made to our reference 381212.I thank you for getting closer to the technical nurse, who meets this difficulty.

• Brand Name: INSYTE YEL 24GA X 0.75IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8685146
• MDR Text Key: 150174758
• Report Number: 8041187-2019-00438
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812128
• UDI-Public: 30382903812128
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381212
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other