MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00"; INTRAVASCULAR CATHETER

Catalog Number	392633
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that iag bc pro wing pnk 20ga x 1.0in was leaking and cracked at the hub.It was reported by customer that iv was inserted successfully in patient.Once inserted and hooked up to iv fluids, rn noticed iv was leaking under dressing, and then noticed iv hub was broken / cracked.
Additional Manufacturer Narrative
Investigation results: received 2 broken catheter adapters of a 20gx1.00in insyte autoguard device from lot 3222374 for the investigation of this complaint.A photograph was also provided for investigation, which resembled the returned samples.A gross visual inspection of the returned samples shows two catheter adapters that are broken near the push tab.One adapter was missing the distal end that was connected to the catheter.It was present in the photo, but was not provided for investigation.The two parts of the other adapter were returned.The end with the catheter shows the same physical damage as the luer end.The fracture on this end is aligned with the perimeter of the wedge.The fracture is not smooth but rather jagged as some extreme force was apply to the unit tough a point of contact cannot be determined.The type of damage observed is most commonly observed in a u shape around the adapter.If existing crack is present, the adapter could come into 2 pieces during use.Based on the location and shape of the crack, the observed defect mostly likely originated during the zone five manufacturing process.Misalignment of the rotating gripers with respect to the pick and place grippers can caused a cracked adapter.The misalignment would cause contact before the adapter rotate operation is completed.Visual inspections for damaged/cracked adapters and leak testing are performed periodically per the sampling plan to mitigate the risk of this defect.Preventative maintenance (pm¿s) is also performed periodically to ensure proper functioning of the equipment.The manufacturing personnel were notified of this complaint.Investigation conclusion(s): the defect of catheter broke/separated after placement was confirmed.Probable root cause conclusion(s): manufacturing.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOGUARD BC PRO WINGED, 20G X 1.00"
• Common Device Name: INTRAVASCULAR 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: 18522680
• Report Number: 1710034-2024-00014
• Device Sequence Number: 15490243
• Product Code: FOZ
• UDI-Device Identifier: 00382903926336
• UDI-Public: (01)00382903926336
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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: Other
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: 392633
• Device Lot Number: 3222374
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown