MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 26G (1.9 FR) X 1.9 CM BD INTROSYTE-N AUTOGUARD SHIELDED INTRODUCER; INTERVASCULAR CATHETER

Catalog Number	384008
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 a breakage occurred during use with a 26g (1.9 fr) x 1.9 cm bd introsyte-n autoguard shielded introducer.The following information was provided by the initial reporter.I received a risk master from nicu regarding a bd 26 gauge introsyte-n autoguard shielded introducer.It states that the introducer tore and broke while trying to tear it apart.They were unable to get the introducer off and had to pull the picc out and restick.Can you hook me up with the person i should report this to at bd? this has happened a few times since february.Thank you." per phone call: specified that the product # 384008 and lot # 8297893 was the affected device.She did not have any specific dates or patient info in their system and had just heard about the past issues via word of mouth from the nurses.No issues or harm just had to restick the infant.She has the broken device and can send it back." 1 of 2 complaints.
Event or Problem Description
It was reported that a breakage occurred during use with a 26g (1.9 fr) x 1.9 cm bd introsyte-n autoguard shielded introducer.The following information was provided by the initial reporter, i received a risk master from nicu regarding a bd 26 gauge introsyte-n autoguard shielded introducer.It states that the introducer tore and broke while trying to tear it apart.They were unable to get the introducer off and had to pull the picc out and restick.Can you hook me up with the person i should report this to at bd? this has happened a few times since february.Thank you." per phone call: specified that the product # 384008 and lot # 8297893 was the affected device.She did not have any specific dates or patient info in their system and had just heard about the past issues via word of mouth from the nurses.No issues or harm just had to restick the infant.She has the broken device and can send it back." 1 of 2 complaints.
Additional Manufacturer Narrative
H.6.Investigation: bd received 49 introsyte-n autoguard introducer 26 gauge units from lot 8297893 for evaluation.There were 47 returned units in sealed packaging and 2 used units in opened packages.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 sealed units and observed no physical/mechanical damage to the units.The units all had the appropriate indicators and no resistance was felt when attempting to peel the sheath.Next, the two used units were inspected and they were missing the appropriate indicators 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, having the heat too high during the tipping process.

• Brand Name: 26G (1.9 FR) X 1.9 CM BD INTROSYTE-N AUTOGUARD SHIELDED INTRODUCER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8744475
• Report Number: 1710034-2019-00689
• Device Sequence Number: 14084174
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/28/2019
• 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