MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD IAG BC PRO GLOBAL PNK 20GA X 1.16IN; PERIPHERAL IV CATHETER

Catalog Number	381034
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd iag bc pro global pnk 20ga x 1.16in had leakage at the catheter junction.The following information was provided by the initial reporter translated from french to english: (b)(6): 25-jun-2024.Follow-up 1st attempt comments (rec): attached the e-mail in "attachment(s)" field below "1.Could you please provide a date of event? "18/06/2024".2.Please confirm the number of products affected."1 device only".3.Has there been any patient impact (serious injury, medical intervention, change of treatment required)? "catheter change, patient reperfusion".4.Has there been any healthcare worker¿s exposure to blood or bodily fluids? "no" 5.Have any other actions been taken? "no".6.Were there any negative consequences for the operator due to the leak or for patients due to the missed administration? "no".We would also like to know if samples are available for the survey.If so, could you tell us whether they are used or unused samples, and if so, whether they are contaminated with blood or cytotoxic drugs."yes, the device is available." "yes, the catheter has been used; it is contaminated." in order to organize the return of the samples, we would need you to provide us with a pick-up address, including the name and number of the person to contact, and we will schedule a pick-up of the samples by our tnt carrier."return address: to maëlle de kerautem, interne en pharmacie service pharmacie centre hospitalier loire vendée océan boulevard guérin 85300 challans 02.51.49.50.61".I'm currently a pharmacy intern at the challans hospital, in charge of material vigilance.We've had an incident with the insyte autogard bc pro catheter (ref 381034, batch 4072333).There is a hole in the catheter at the level of the non-return valve, causing a leak, with the clinical consequence of having to reperfuse the patient.The device is available for expert appraisal.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results our quality engineer inspected the sample submitted for evaluation.Bd received one 20g insyte autoguard bc iv catheter which exhibited evidence of use.The actuator had been advanced through the blood control valve.A microscopic examination of the catheter adapter revealed a breach in the adapter.The location of the breach coincided with the flared end of the wedge.Your reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the molding process.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD IAG BC PRO GLOBAL PNK 20GA X 1.16IN
• Common Device Name: PERIPHERAL IV CATHETER
• 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: 19766185
• Report Number: 1710034-2024-00733
• Device Sequence Number: 20960821
• Product Code: FOZ
• UDI-Device Identifier: 00382903810345
• UDI-Public: (01)00382903810345
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381034
• Device Lot Number: 4072333
• 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: 06/21/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown