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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381423
Device Problem Failure to Advance (2524)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/12/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a bd insyte¿ autoguard¿ shielded iv catheter made a puncture site larger than the catheter remaining in patient causing a back flow of blood under the tegaderm.Nurses also reported the following, "received flash when inserting iv but unable to advance catheter.Product is flimsy and unable to advance into the vein.Upon insertion received flash and was visibly in the vein, however catheter was unable to advance into the vein.Catheter is flimsy and bends when attempts to advance are made.".
 
Event Description
It was reported that a bd insyte¿ autoguard¿ shielded iv catheter made a puncture site larger than the catheter remaining in patient causing a back flow of blood under the tegaderm.Nurses also reported the following, "received flash when inserting iv but unable to advance catheter.Product is flimsy and unable to advance into the vein.Upon insertion received flash and was visibly in the vein, however catheter was unable to advance into the vein.Catheter is flimsy and bends when attempts to advance are made.".
 
Manufacturer Narrative
H.6.Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect.Received 10 unused iag 22ga units in sealed packages and one package label catalog number 381423; lot number 8620657.Photo displayed two package labels which revealed the bd logo, ref no., description, lot number and the expiration date.One is the old label and one is the new label penetration and drag test were performed: during the penetration and drag test the catheter did not accordion, bend, kink, split or wrinkle during insertion.Specification is 32 grams max for needle tip, 35 grams max for catheter tip and 10 grams average for catheter drag.The units were acceptable per specification.Visual/microscopic examination: the bevel area had the proper bevel cut and the secondary bevel was present.The needle was not bent, pinched or gripper damage to the needles.There was no mechanical/physical damage to the spring, needle hub, grip, or evidence of glue on the button or hub.The needle was not bent, pinched or damaged.Lie distance: within the acceptable range of.001 - 0.023 inches.Cannula tip quality: rated at a and b, acceptable.No bends, cuts, holes, kinks, splits, kinks, wrinkles or the characteristic v shape of a spear thru was observed in the tubing of the catheter.Catheter tip grading: all catheter tips were graded a 4, acceptable.Tip adhesion: holding the catheter hub, manually rotated the clear barrels 360 degrees, observed no candy caning and there was no stickiness felt.Based on the review of the submitted photo the defect needle penetration difficult/painful was not identified or confirmed.The photo was of two package labels.The defect penetration difficult was not identified or confirmed with the returned unit.The returned units did not display any adverse characteristics that would contribute to the defect the customer experienced.There was no physical evidence to confirm or support manufacturing process related issues for the reported defect.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key8412112
MDR Text Key138651557
Report Number1710034-2019-00274
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903814238
UDI-Public30382903814238
Combination Product (y/n)N
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2021
Device Catalogue Number381423
Device Lot Number8260657
Date Manufacturer Received02/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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