MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-W WINGED YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number 381312

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd insyte-w winged yel 24ga x 0.75in catheter broke the following information was provided by the initial reporter: the patient was 1 year old and 6 months old and placed an insyte indwelling needle on sunday, and the normal infusion was made on february 20, and the abnormality was found on the morning of the 21st, only a small half was cut outside, and the superficial subcutaneous vein was found to have 15mm imaging around the eye of the needle on the back of the left hand by imaging examination.At present, the child was arrested by surgery, but the child was not caught by surgery because he was too young.The hospital asked to find a hospital that could perform surgery to arrest successful cases to assist in the operation.

Event Description

The patient was 1 year old and 6 months old and placed an insyte indwelling needle on sunday, and the normal infusion was made on february 2 0, and the abnormality was found on the morning of the 21st, only a small half was cut outside, and the superficial subcutaneous vein was found to have 15mm imaging around the eye of the needle on the back of the left hand by imaging examination.At present, the child was arrested by surgery, but the child was not caught by surgery because he was too young.The hospital asked to find a hospital that could perform surgery to arrest successful cases to assist in the operation.

Manufacturer Narrative

Based on device history record review, no abnormality was observed during the production run.The catheter separation test results for outgoing inspection were within specifications.From the returned photos, catheter tubing broke off at mid of catheter tubing.The assembly process was reviewed, and the only station that is in contact with the catheter tubing is the rubber pads at the flaring station.Given the elastic nature of the rubber pads and there are no sharp or hard edges on the pads, this station is unlikely to cause damage on the catheter tubing to result in reported defect.As current control for catheter damage, there is an outgoing functional test in place to check for catheter to adapter pull force.There is also an outgoing visual inspection and in-process visual inspection in place to check for catheter damage.As the actual sample not returned, actual root cause could not be established.

• Brand Name: BD INSYTE-W WINGED YEL 24GA X 0.75IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18908663
• MDR Text Key: 337729897
• Report Number: 2243072-2024-00285
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903813124
• UDI-Public: (01)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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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: 381312
• Device Lot Number: 3237874
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 18 MO