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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER
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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER Back to Search Results
Catalog Number 388333
Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/26/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that bd angiocath¿ iv catheter broke off inside the patient.An x-ray was performed to locate the material.An attempt was made to remove the material through a cut over the region of the vein punctured, but could not remove the product.The patient stayed in the hospital longer than originally planned.There was surgical intervention for withdrawal.
 
Manufacturer Narrative
Investigation summary: received one used catheter/adapter assembly and a package label on 12/03/2018 from catalog number 388333, lot number 7333968 at bd juiz de fora.Dhr review: a review of the device history record was completed for sub-assembly #008651bjf lot 7270726 manufactured from 29-sep-17 to 24-oct-17 in asam machines 01 and 02 used in claimed lot 7333968.The batch was analyzed for pull force catheter adapter¿ tests, and it was evidenced record of results of fail in this test.Based on these results were opened the quality notifications #200711225; 200711628 e 200717568 of low pull force catheter adapter, but is not related to this claim since the incident was caused by a failure to use the product and not by a manufacturing defect of the product.Dhr review: a review of the device history record was completed for sub-assembly #008651bjf lot 7299952 manufactured from 13-nov-17 to 30-nov-17 in asam machines 01 and 03 used in claimed lot 7333968.The batch was analyzed for pull force catheter adapter¿ tests and no records were found out of specification that could lead to this issue.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of catheter broke / separated after placement with lot #7333968 regarding item #388333.Investigation conclusion: the returned sample was visually analyzed under magnification was it was identified that a part of the catheter remaining inside the adapter was probably twisted during removal from the patient's vein.This sample was sent to bd usa - franklin lakes to ct scan test to check if all rest of the catheter is remained gripped inside the adapter.The ct scan test was completed on the sample and it was possible to confirm the hypothesis of twisting of the catheter during its removal.The teflon tubing did not drop from the connection with plastic adapter as claimed.Bd was unable to verify the reported issue.It is clear that the connection between tubing and metal wedge inside the adapter remains fixed.Also is possible to see in the sample that the teflon tubing was stressed, stretched out and twisted, prior to the rupture during the catheter removal from the patient after infusion therapy.Root cause description: although three quality notification has been evidenced catheter / adapter low pull force during the investigation conducted, it is not possible to state that these nonconformities are in fact related to this complaint since the incident was caused by a failure in the use the product and not by a manufacturing defect of the product.Rationale: complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.
 
Event Description
It was reported that bd angiocath¿ iv catheter broke off inside the patient.An x-ray was performed to locate the material.An attempt was made to remove the material through a cut over the region of the vein punctured, but could not remove the product.The patient stayed in the hospital longer than originally planned.There was surgical intervention for withdrawal.
 
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Brand Name
BD ANGIOCATH¿ IV CATHETER
Type of Device
IV CATHETER
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
MDR Report Key8056684
MDR Text Key126882065
Report Number9610048-2018-00194
Device Sequence Number0
Product Code FOZ
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2022
Device Catalogue Number388333
Device Lot Number7333968
Date Manufacturer Received10/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
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