MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO GLOBAL; PERIPHERAL IV CATHETERS

Catalog Number	381034
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that bd iag bc pro global catheter broke.The following information was provided by the initial reporter: tip of cannula has broken off as mo withdrawing whole unit.Mo attempting to withdraw blood sample when noticed ballooning and pt complained of soreness in left cubital fossa.Withdrew cannula and tip snapped.Torniquet applied and urgent uss required.Tip has been surgically removed - lodged in subcutaneous tissue.
Additional Manufacturer Narrative
Investigation results: the complaint of a break in the iv catheter tubing was confirmed; however, the root cause could not be determined.Two 20g insyte autoguard iv catheters were provided for investigation.The length of one iv catheter was shorter than the other.The shorter iv catheter exhibited evidence of use and a microscopic examination of the iv catheter tubing revealed an uneven surface at the tip.The cross section exhibited evidence of a sharp instrument cut.A longitudinal scoreline was observed in the tubing leading to the sharp instrument damage.A breach in the iv catheter that was consistent with needle puncture damage was also observed near the broken end of the iv catheter.It is possible that the iv catheter was damaged by a needle during insertion; however, the specific mechanism of damage could not be determined.Had the needle punctured the tubing during manufacturing, the damage would likely preclude insertion of the device.The instructions for use (ifu) indicate that if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur.A quality notification for needle puncture damage in the iv catheter tubing was generated during the production of this batch.However, it could not be determined if that incident contributed to the failure observed on the sample.No other similar complaints were reported from the implicated lot.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.

• Brand Name: BD IAG BC PRO GLOBAL
• 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: 19840381
• Report Number: 1710034-2024-00782
• Device Sequence Number: 7594950
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 09/24/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 381034
• Device Lot Number: 3278230
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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