MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANGIOCATH SPECIAL GRAY 16GA X 5.25IN; INTRAVASCULAR CATHETER

Model Number	382259
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the angiocath special gray 16ga x 5.25in as it was removed the needle broke.Forceps were use to remove the broken needle from the patient.The following information was provided by the initial reporter, translated from french to english: when performing a nephrostomy, the radiologist stabbed the patient's kidney transcutaneously.After removal of the mandrel, the needle separated from the plastic support located at the end of the mandrel and straightened in the body of the patient.The mandrel had to be removed from the patient with a forceps but the maneuver was very difficult.
Event or Problem Description
It was reported that during use of the angiocath special gray 16ga x 5.25in as it was removed the needle broke.Forceps were use to remove the broken needle from the patient.The following information was provided by the initial reporter, translated from french to english: when performing a nephrostomy, the radiologist stabbed the patient's kidney transcutaneously.After removal of the mandrel, the needle separated from the plastic support located at the end of the mandrel and straightened in the body of the patient.The mandrel had to be removed from the patient with a forceps but the maneuver was very difficult.
Additional Manufacturer Narrative
H.6.Investigation: one sample was provided for evaluation by our quality engineer team.Through examination of the provided sample, a separation between the needle and the hub was observed.The observed defect is related to a lack of epoxy within the needle hub resulting from improper application.A device history record review was performed for the provided lot number and the review did not reveal any detected quality issues during the production process.Bd was able to duplicate and confirm by the customer indicated failure mode.

• Brand Name: ANGIOCATH SPECIAL GRAY 16GA X 5.25IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9255584
• Report Number: 9610847-2019-00651
• Device Sequence Number: 3730551
• Product Code: FOZ
• UDI-Device Identifier: 30382903822592
• UDI-Public: 30382903822592
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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: 03/31/2023
• Device Model Number: 382259
• Device Catalogue Number: 382259
• Device Lot Number: 8078974
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention