MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INTRODUCER INTROSYTE-N 1.9F 1.9CM; CATHETER INTRODUCER

Catalog Number	384021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
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 that introducer introsyte-n 1.9f 1.9cm sheath broke.The following information was provided by the initial reporter: it was reported that nnp slid introducer catheter out and went to peel it away.Nnp grabbed the purple wings to snap and peel away and one of the purple wings completely broke off before the peeling could be completed.  verbatim: describe the event or problem: neonatal nurse practitioner (nnp) placed a picc line into patient using introsyte-n introducer.After vein was accessed, the needle was moved and picc catheter advanced without difficulty.Nnp slid introducer catheter out and went to peel it away.Nnp grabbed the purple wings to snap and peel away and one of the purple wings completely broke off before the peeling could be completed.So there was no way to continue to remove the peel away catheter.Nnp had to have another nnp scrub in to hold picc catheter in place while tweezers were used to slowly pick off the rest of the peel away catheter.This was successful and no harm occurred.
Event or Problem Description
It was reported that introducer introsyte-n 1.9f 1.9cm sheath broke.The following information was provided by the initial reporter: it was reported that nnp slid introducer catheter out and went to peel it away.Nnp grabbed the purple wings to snap and peel away and one of the purple wings completely broke off before the peeling could be completed.  verbatim: describe the event or problem: neonatal nurse practitioner (nnp) placed a picc line into patient using introsyte-n introducer.After vein was accessed, the needle was moved and picc catheter advanced without difficulty.Nnp slid introducer catheter out and went to peel it away.Nnp grabbed the purple wings to snap and peel away and one of the purple wings completely broke off before the peeling could be completed.So there was no way to continue to remove the peel away catheter.Nnp had to have another nnp scrub in to hold picc catheter in place while tweezers were used to slowly pick off the rest of the peel away catheter.This was successful and no harm occurred.
Additional Manufacturer Narrative
H.6.Investigation: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

• Brand Name: INTRODUCER INTROSYTE-N 1.9F 1.9CM
• Common Device Name: CATHETER INTRODUCER
• 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: 12636537
• Report Number: 1710034-2021-00886
• Device Sequence Number: 17215920
• Product Code: DYB
• UDI-Device Identifier: 00382903840212
• UDI-Public: 00382903840212
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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: 12/31/2023
• Device Catalogue Number: 384021
• Device Lot Number: 1005635
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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 Age: 6 DA
• Patient Sex: Male