MAUDE Adverse Event Report: BECTON DICKINSON BD INTRODUCER INTROSYTE-N 1.9F 1.9CM; INTRAVASCULAR CATHETER

Catalog Number	384021
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
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 bd introducer introsyte-n 1.9f 1.9cm catheter was defective/damaged the following information was provided by the initial reporter; it was reported by customer that " after picc insertion through an introducer, i attempted to "peel" the introducer back to remove it off of the picc catheter and one side stuck to the catheter causing difficulty removing the remaining introducer fragments off the picc catheter potentially causing damage to the picc catheter" verbatim from the customer: " after picc insertion through an introducer, i attempted to "peel" the introducer back to remove it off of the picc catheter and one side stuck to the catheter causing difficulty removing the remaining introducer fragments off the picc catheter potentially causing damage to the picc catheter".
Additional Manufacturer Narrative
Our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of catheter defective / damaged was confirmed upon inspection and testing of the sample.Analysis of the sample showed that the catheter had broken in two.Bd determined that the cause of the failure could be related to our tip forming process.A retraining has been performed with all manufacturing personnel involved in the tip forming process, to prevent the reoccurrence of this failure mode.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
No additional information provided.

• Brand Name: BD INTRODUCER INTROSYTE-N 1.9F 1.9CM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales UT ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18242665
• Report Number: 2243072-2023-02121
• Device Sequence Number: 6685920
• Product Code: FOZ
• UDI-Device Identifier: 50382903840217
• UDI-Public: (01)50382903840217
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 04/30/2026
• Device Catalogue Number: 384021
• Device Lot Number: 3123402
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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