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U.S. Department of Health and Human Services

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

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 26G (1.9FR) X 1.9CM BD INTROSYTE-N¿ AUTOGUARD¿ SHIELDED INTRODUCER; NEONATAL, CATHETER INTRODUCER Back to Search Results
Catalog Number 384008
Device Problems Break (1069); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/07/2016
Event Type  Injury  
Manufacturer Narrative
The date of event is unknown.The date received by the manufacturer is used.Medical device lot #.The customer provided lot 11142412 however, this could not be verified as a valid lot number.(b)(4).It is unknown if a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.See manufacturer narrative.
 
Event Description
It was reported that while attempting to place a midline catheter in the neonatal icu, the part of the introducer that gets torn in half and taken off in order to advance the catheter broke and wasn't able to be completely removed.The whole line had to be removed and the neonate stuck again.
 
Manufacturer Narrative
Device evaluation: result - one used 26g bd introsyte-n autoguard shielded introducer without packaging was received for evaluation.The unit consisted of the splittable sheath (split in two portions).Accompanying the unit was a label from an l-cath picc s/l ref.384539.A visual/microscopic examination was performed and it was observed that each portion of the peel-away sheath was broken at the tabs and partially peeled down the tubing.The peel-away sheath revealed stress and jagged edges to near midway of the tubing where the portion revealed separation by stress.The edges revealed that the break at the tabs occurred at the skive line on both tabs yet then deviated from the skive line on one side of the tubing.Examination revealed separation by stress resulted in jagged edges.The skive line was present on both sides of the peel away catheter tubing.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion - confirmation of the defect as stated by the customer was conclusive with the used unit provided for this incident.The unit displayed the characteristics of jagged separation with stress along the peel and evidence of deviating from the skive line resulting in a jagged break at the peel away tubing.Based on the evaluation of the returned unit it was indicative that the cause of failure was induced by deviating from the skive line during the peel and stress to the unit in the clinical environment.
 
Event Description
The resource specialist for women & children reported this defect has happened more than once before.Chg was the solution used to prep the site.
 
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Brand Name
26G (1.9FR) X 1.9CM BD INTROSYTE-N¿ AUTOGUARD¿ SHIELDED INTRODUCER
Type of Device
NEONATAL, 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6202512
MDR Text Key63224095
Report Number1710034-2016-00067
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/23/2017
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
Device Operator Health Professional
Device Catalogue Number384008
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2016
Initial Date FDA Received12/23/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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