MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED 20GX1"; INTRAVASCULAR CATHETER

Catalog Number	382933
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Pain (1994); Skin Inflammation/ Irritation (4545)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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 while using bd insyte autoguard bc pro winged 20gx1" the catheter sheared and foreign matter remained in the patient.The following information was provided by the initial reporter: short description: foreign body cephalic vein.When did the incident occur? during use.Detailed incident description: a foreign body remained in the cephalic vein at the level of the patient's left eapula.A fragment of catheter.It will be removed in the operating room.The catheter was inserted into the left fold of the patient's arm on 14 august without any difficulty.It was removed the same day.There was some redness, but the puncture site was clean.On 28 august, the patient reported pain in her arm.We don't have the batch number.
Event or Problem Description
It was reported while using bd insyte autoguard bc pro winged 20gx1" the catheter sheared and foreign matter remained in the patient.The following information was provided by the initial reporter: short description: foreign body cephalic vein when did the incident occur? during use detailed incident description a foreign body remained in the cephalic vein at the level of the patient's left eapula.A fragment of catheter.It will be removed in the operating room.------ the catheter was inserted into the left fold of the patient's arm on (b)(6) without any difficulty.It was removed the same day.There was some redness, but the puncture site was clean.On (b)(6), the patient reported pain in her arm.We don't have the batch number.
Additional Manufacturer Narrative
H6: investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.

• Brand Name: BD INSYTE AUTOGUARD BC PRO WINGED 20GX1"
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17763537
• Report Number: 1710034-2023-01068
• Device Sequence Number: 7094335
• Product Code: FOZ
• UDI-Device Identifier: 00382903829330
• UDI-Public: (01)00382903829330
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: Other
• Device Catalogue Number: 382933
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown