MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-W WINGED BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381323
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd insyte-w winged bl 22ga x 1.0in catheter broke/ separated after placement the patient underwent conventional orthopedic spine surgery with unstable blood pressure, and invasive blood pressure monitoring of the radial artery was performed on july 11.On the second postoperative day, the blood pressure and respiration were stabilized, and the muscle strength of the limbs was restored, and invasive arterial cannulae were removed, and the cephalic end of the cannulae was observed to appear to be fractured into 2 segments, with localized redness, swelling, and discomfort in the affected area after removal.Bedside ultrasonography did not show any obvious stump retention in the body.The patient was treated with localized anti-inflammatory and anti-swelling medications, and the affected area was closely observed for any changes, and ultrasonography was performed when necessary to determine whether there was any residual stump retention.
Additional 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, the catheter tubing was observed to break off at mid-section of the catheter tubing.However, at the breakage point, both sides of the tubing were observed to have a clean cut, with no visible damage could be observed on the 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 was not returned for evaluation, the actual root cause could not be established.
Event or Problem Description
The patient underwent conventional orthopedic spine surgery with unstable blood pressure, and invasive blood pressure monitoring of the radial artery was performed on (b)(6).On the second postoperative day, the blood pressure and respiration were stabilized, and the muscle strength of the limbs was restored, and invasive arterial cannulae were removed, and the cephalic end of the cannulae was observed to appear to be fractured into 2 segments, with localized redness, swelling, and discomfort in the affected area after removal.Bedside ultrasonography did not show any obvious stump retention in the body.The patient was treated with localized anti-inflammatory and anti-swelling medications, and the affected area was closely observed for any changes, and ultrasonography was performed when necessary to determine whether there was any residual stump retention.

• Brand Name: BD INSYTE-W WINGED BL 22GA X 1.0IN
• Common Device Name: 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: 20101882
• Report Number: 2243072-2024-00935
• Device Sequence Number: 15421199
• Product Code: FOZ
• UDI-Device Identifier: 00382903813230
• UDI-Public: (01)00382903813230(11)231130(17)281031(10)3311961
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381323
• Device Lot Number: 3311961
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown