MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTROSYTE-N; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

Model Number	384021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd introsyte-n¿ catheter broke while inserting into hub.The following information was provided by the initial reporter, translated from (b)(6) to english: "picc catheter broke insertion of the hub, after an unsuccessful attempt to pass the picc." we have the packaging segregated for analysis, the material was contaminated.Additionally, the customer provided the following additional information: "the entire procedure to be performed, such as the passage of the picc catheter, the nurse sets up the table and tests the device.The catheter is lubricated with saline, the introducer is lubricated as well and the needle is removed.At this moment we realized that the needle was tearing the introducer, so the bevel was blunt.So it was decided not to use this device and request another one, as it was going to harm the puncture a lot.For he was a child who had capillary fragility and multiple punctures.".
Event or Problem Description
It was reported that while using bd introsyte-n¿ catheter broke while inserting into hub.The following information was provided by the initial reporter, translated from portuguese to english: "picc catheter broke insertion of the hub, after an unsuccessful attempt to pass the picc".We have the packaging segregated for analysis, the material was contaminated.Additionally, the customer provided the following additional information: "the entire procedure to be performed, such as the passage of the picc catheter, the nurse sets up the table and tests the device.The catheter is lubricated with saline, the introducer is lubricated as well and the needle is removed.At this moment we realized that the needle was tearing the introducer, so the bevel was blunt.So it was decided not to use this device and request another one, as it was going to harm the puncture a lot.For he was a child who had capillary fragility and multiple punctures".
Additional Manufacturer Narrative
H6: investigation summary our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed the reported product with the reported defective/damaged catheter.The reported issue was not confirmed upon inspection of the supplied photo since the image is not clear.The root cause of the defect could not be determined since the defect was not confirmed.A device history record review showed no non-conformances associated with this issue during the production of this batch.Quality records have been consulted for tracking and trending purposes this is the first issue reported for the reported lot, which means low occurrence.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.H3 other text : see h10.

• Brand Name: BD INTROSYTE-N
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11697979
• Report Number: 1710034-2021-00321
• Device Sequence Number: 3128739
• Product Code: FOZ
• UDI-Device Identifier: 50382903840217
• UDI-Public: 50382903840217
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K974764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 05/31/2023
• Device Model Number: 384021
• Device Catalogue Number: 384021
• Device Lot Number: 0164203
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1