MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INTRODUCER INTROSYTE 3F 3.2CM; INTRAVASCULAR CATHETER

Model Number	384030
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default.Initial reporter address: (b)(6).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 introducer introsyte 3f 3.2cm was damaged but still operable.The following information was provided by the initial reporter: "the peripheral insertion catheter was passed and the guide wire was attached, showing a wrinkling of the extension in the attempt to remove it.".
Event or Problem Description
It was reported that introducer introsyte 3f 3.2cm was damaged but still operable.The following information was provided by the initial reporter: "the peripheral insertion catheter was passed and the guide wire was attached, showing a wrinkling of the extension in the attempt to remove it.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/3/2021.H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received ten unused introsyte introducers within sealed packages.The blister packs were sealed inside a miscellaneous plastic packaging with miscellaneous stickers adhered to the plastic packaging.All components were present and intact.Visual observation of the devices revealed that the units had no abnormalities or damage.After visual observation, the needle portion of each unit was pulled back through the splitable sheath, while observing for traction and wrinkling.No abnormalities were observed and each unit demonstrated the needle could be removed with no resistance or damage to the tubing.Bd was unable to confirm any defects related to the returned samples.No further testing could be conducted, as based on the event description issues were experienced while withdrawing the guidewire which remained attached, wrinkling the extension and traction.This could indicate that the experienced issues could be related to the picc and not the introducer as the introducer does not contain a guidewire and the sheath is a splitable sheath (catheter) that is cracked and then split for removal after the picc is fed through it during placement.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: INTRODUCER INTROSYTE 3F 3.2CM
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12444684
• Report Number: 1710034-2021-00793
• Device Sequence Number: 5190861
• Product Code: FOZ
• UDI-Device Identifier: 50382903840309
• UDI-Public: 50382903840309
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 09/30/2021
• Device Model Number: 384030
• Device Catalogue Number: 384030
• Device Lot Number: 8297873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• 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