MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER; INFUSION CATHETER

Catalog Number 383405

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Difficult to Advance (2920)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 07/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Results: a sample is not available for evaluation, but three images showing the defective sample were evaluated and showed the reported defect.The manufacturing plant qa tested the pull force of the retention samples of this batch, with results meeting specifications.A review of the device history records for revealed no irregularities during the manufacture of the reported lot number 5019004.A manufacturing review revealed no related issues during production.Conclusion: although the photos provided showed a broken catheter, an absolute root cause for this incident cannot be determined.However, our quality engineer notes that a probable cause for this incident is re-cannulation.If the cannula is pushed forward when inserting the catheter there is a risk that the catheter can be pierced by the cannula tip and the catheter can be broken when pulled out of a vein.

Event Description

It is reported that the nurse, while inserting catheter, saw blood "flash" back, then "felt resistance when delivering the catheter." the patient withdrew her hand in pain.When the nurse pulled the catheter back out of the vein, the catheter was found to be 1.3cm shorter than normal.First a dissection near the insertion site then a subsequent ultrasound were performed, without finding the catheter.The patient was advised to transfer to another hospital for x-ray study, as there was no x-ray machine available in the hospital where she was.No further information regarding the patientmedical treatment was provided.

Manufacturer Narrative

Correction: medical device brand name: bd intima ii iv catheter.Additional information: describe event or problem: additional patient information was received: the failed iv start was in the "back of right hand." it was originally reported that "she was advised to transfer hospital for x-ray as there is no x-ray machine in current hospital." subsequent information states that "the vessel at 1cm from the puncture site was incised to look for it blindly but failed, then b-mode ultrasound was used to look for it but also failed, and finally the patient was transferred." the receiving hospital and mode of transportation are unknown.

Event Description

Additional patient information was received.The failed iv start was in the "back of right hand." it was originally reported that "she was advised to transfer hospital for x-ray as there is no x-ray machine in current hospital." subsequent information states that "the vessel at 1cm from the puncture site was incised to look for it blindly but failed, then b-mode ultrasound was used to look for it but also failed, and finally the patient was transferred." the receiving hospital and mode of transportation are unknown.

• Brand Name: BD INTIMA II¿ IV CATHETER
• Type of Device: INFUSION CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5887194
• MDR Text Key: 52490119
• Report Number: 3006948883-2016-00021
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143610
• 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: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 383405
• Device Lot Number: 5019004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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): Required Intervention
• Patient Age: 29 YR