MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿; INTRAVASCULAR CATHETER

Catalog Number 388311

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).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 during use a bd insyte was found leaking as ¿after the patient's canalization, blood was seen leaking out of the catheter cone, the catheter was removed.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: not confirmed: bd was unable to confirm the incidents of ¿peelback¿ and ¿leakage¿.Investigation comments: it was not possible to confirm this claim, since the client's photos containing the sample claimed did not demonstrate the defect claimed as ¿peelback¿ and ¿leakage¿.In addition, batch history analysis and nonconformity analysis did not demonstrate clear evidence of the incident in question.Samples/ photos: after analyzing the photos, no defects were observed in the product, since the photos did not have a good resolution.According to the analysis of the attached photo "photo", it can be seen that the tip of the catheter was crooked, but the set catheter/ adapter assembled had been moved from its original position, therefore, it is not possible to know if the observed characteristic comes from the manufacture the product or the handling of the product during its use.Dhr review: the following assembly batches used in the final claimed product list 7118819 were analyzed: the final assembly lot: 711607 assembled at (b)(4) in the period from 05 to 05/05/2017.The assembly lot of the catheter: 7116622 performed at (b)(4) in the period from 05 to 05/05/2017.Both batches were tested for damaged catheter, transfixed catheter, and leak tests in addition to all other tests, and no records were found that could clearly point to a cause of "peel back" and "leakage" defects.Qn/ ncmr review: no records of quality notification or reports of non-conformity that could lead to incidents in to the lot involved in this complaint were evidenced.Investigation conclusion: based on the information of this complaint, it was not possible to determine a root cause for this issue.

• Brand Name: BD INSYTE¿
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7342197
• MDR Text Key: 102734556
• Report Number: 9610048-2018-00026
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 388311
• Device Lot Number: 7118819
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other