MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AG BC GLOBAL WING; PERIPHERAL IV CATHETERS

Catalog Number	382934
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bd insyte ag bc global wing catheter broke.The following information was provided by the initial reporter: we recently encountered a critical issue with one of your products, specifically the pink cannula used for blood control.During a surgical procedure, it was observed that the cannula had broken off inside the patient¿s body.A subsequent ct scan confirmed the presence of the cannula fragment inside the patient.This necessitated an additional surgery to remove the broken piece.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Investigation results: the complaint of a break in the catheter was confirmed; however, the root cause could not be determined from the three photographs or three 20g insyte autoguard iv catheters that were provided for investigation.The returned samples resembled the 20g insyte autoguard iv catheters that were shown in the photos.One catheter was received in two segments.The features of the adjoining ends of the catheter tubing suggest that needle puncture damage may have been a potential contributing factor of the catheter break; however the root cause could not be determined.As the device had been opened and exhibited evidence of use, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.No other similar complaints were reported from the lot.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.The unused 20g insyte autoguard device was received with the needle fully retracted.As the device was received in a sealed unit package, the premature retraction likely occurred during assembly.The appropriate manufacturing personnel were notified of this issue, which was unrelated to the reported catheter break.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of a break in the catheter was confirmed; however, the root cause could not be determined from the photographs that were provided for investigation.The photos showed two 20g insyte autoguard iv catheters with different lengths.Compared with the other iv catheter, one catheter extended only a short distance from the catheter adapter.As the device had been opened and exhibited evidence of use, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.There were no distinguishing features in the photograph which could aid in identification of a specific root cause.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AG BC GLOBAL WING
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20273390
• Report Number: 1710034-2024-01040
• Device Sequence Number: 3505363
• Product Code: FOZ
• UDI-Device Identifier: 00382903829347
• UDI-Public: (01)00382903829347
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2024

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: 382934
• Device Lot Number: 4012508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/02/2024; 11/15/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/02/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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