MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INTROSYTE AUTOGUARD 26G INTRO ONLY; CATHETER INTRODUCER

Model Number	384008
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
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
Fda notified?: the initial reporter also notified the fda via medwatch # mw5102946.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 the introsyte autoguard 26g intro only wings broke off while removing the sheath during use.The following information was provided by the initial reporter: "the rn was attempting to insert a picc line.After the third attempt, she was successful.When blood return noted and inserted the catheter, she broke the wings of the introducer to remove the sheath.The wings broke off and left the sheath on the catheter.She attempted to remove the sheath using hemostats which was unsuccessful, so she had to remove the line.They will have to attempt to insert a picc later on.".
Event or Problem Description
It was reported that the introsyte autoguard 26g intro only wings broke off while removing the sheath during use.The following information was provided by the initial reporter: "the rn was attempting to insert a picc line.After the third attempt, she was successful.When blood return noted and inserted the catheter, she broke the wings of the introducer to remove the sheath.The wings broke off and left the sheath on the catheter.She attempted to remove the sheath using hemostats which was unsuccessful, so she had to remove the line.They will have to attempt to insert a picc later on.".
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the sample and photograph submitted for evaluation.Bd received one photo and one used introducer in three portions: portions 1 and 2 were the handles that had broken apart and separated from the sheath, portion 3 was the sheath with a picc line threaded through it.Visual observation of the portions reveal that the unit had an incorrect peel which resulted in a jagged separation of the tabs and a break from the tubing.Your reported defect was confirmed.Further microscopic observation revealed that there was no skive line present on the length of the sheath indicating the defect is most likely related to the raw material.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: INTROSYTE AUTOGUARD 26G INTRO ONLY
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 12380708
• Report Number: 1710034-2021-00764
• Device Sequence Number: 19850568
• Product Code: DYB
• UDI-Device Identifier: 50382903840088
• UDI-Public: 50382903840088
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/15/2021

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: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 384008
• Device Catalogue Number: 384008
• Device Lot Number: 8297893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1