MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTROSYTE-N¿ PRECISION INTRODUCER; INTRAVASCULAR CATHETER

Model Number	384021
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd introsyte-n¿ precision introducer there was a hole in the sheath.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that "we recently had an issue in our nicu with 3 of the introsyte-n introducers (all on the same patient) where the catheter sheath was punctured through after picc placement attempts.The nnp noticed after the third attempt, that the introducer had a double bevel needle.Our provider team feel quite confident that previously, our picc introducers did not have this double bevel and were labeled simply "introsyte".
Additional Manufacturer Narrative
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 introsyte-n¿ precision introducer there was a hole in the sheath.This occurred 3 times.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that "we recently had an issue in our nicu with 3 of the introsyte-n introducers (all on the same patient) where the catheter sheath was punctured through after picc placement attempts.The nnp noticed after the third attempt, that the introducer had a double bevel needle.Our provider team feel quite confident that previously, our picc introducers did not have this double bevel and were labeled simply "introsyte".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, returned to manufacturer on: 11-jan-2023.H6: investigation summary: our quality engineer inspected the 3 samples submitted for evaluation.The reported issue of catheter broke/separated after placement was confirmed upon inspection of the samples.Analysis of the sample showed that the 3 samples had a broken / separated catheter.Bd determined that the cause of the failure was most likely attributed to use error during the moment of canulation.Dhr was reviewed for this lot numbers and there are no internal rejects related to the reported issue during this order.According to control plan for the manufacturing process, this lots was accepted and meet acceptance criteria.

• Brand Name: BD INTROSYTE-N¿ PRECISION INTRODUCER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16036164
• Report Number: 1710034-2022-00852
• Device Sequence Number: 15260100
• Product Code: FOZ
• UDI-Device Identifier: 50382903840217
• UDI-Public: (01)50382903840217
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K020834
• 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): 03/08/2023

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: 11/30/2024
• Device Model Number: 384021
• Device Catalogue Number: 384021
• Device Lot Number: 1328448
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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
• Patient Sex: Unknown