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

Catalog Number	384008
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Material no.: 384008, batch no.: 8297893.It was reported that during use of the bd introsyte-n autoguard shielded introducer the introducer tore and broke while trying to peel it apart.The central line was reinserted.The incident occurred on (b)(6) 2019.Baby girl, (b)(6).Picc line placed at left antecubital.When trying to remove the introducer off of the line one of the purple pieces broke off making it impossible to get the introducer sheath off of the line.Line had to be pulled out and baby re-stuck again.
Event or Problem Description
Material no.: 384008 batch no.: 8297893.It was reported that during use of the bd introsyte-n autoguard shielded introducer the introducer tore and broke while trying to peel it apart.The central line was reinserted.The incident occurred on (b)(6) 2019.Baby girl, 2 days old.Picc line placed at left antecubital.When trying to remove the introducer off of the line one of the purple pieces broke off making it impossible to get the introducer sheath off of the line.Line had to be pulled out and baby re-stuck again.
Additional Manufacturer Narrative
H.6.Investigation: bd received 2 introsyte-n autoguard introducer 26 gauge units from lot 8297893 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and they were missing the appropriate indicators along the peel away sheath.Next, the engineer attempted to peel the sheath and resistance was felt during peeling.Based off the visual inspection and testing the engineer was able to verify the reported defect.This was determined to have been a manufacturing defect.

• Brand Name: BD INTROSYTE-N AUTOGUARD SHIELDED INTRODUCER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8760194
• Report Number: 1710034-2019-00709
• Device Sequence Number: 1330347
• Product Code: DYB
• UDI-Device Identifier: 50382903840088
• UDI-Public: 50382903840088
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 384008
• Device Lot Number: 8297893
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 DA