MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383407

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Results: investigation summary: actual sample was received and decontaminated by(b)(6).No retention samples were evaluated.The customer returned a sample of 22g defect, close to the catheter adapter of the catheter has broken and the section of the catheter is smooth, the residual of broken catheter was about 2mm.A review of the device history record could not be performed as a lot number was not provided for this incident.According to the original information in the complaint ¿puncture on (b)(6) the infusion ended on (b)(6) and found that there were drums and exudate, and then the catheter was broken when catheter was removed.¿ the information given shows: the sample was transfused for six days and the transfusion for six days were normal.During the six-day infusion, there is no breakage.To sum up, the product has not abnormality in the process of puncture and infusion.In summary, bd (b)(4) cannot confirm no defect related with the factory.The defect sample returned by the customer, revealed the catheter section smooth.After six days of infusion, the infusion was not abnormal.During the infusion, the sample was damaged or broke and the cause of the defect was not confirmed.Conclusion : although the reported defect was confirmed by visual inspection, an absolute root cause for this incident cannot be determined.No capa is required.

Event Description

It was reported that following the sixth infusion, while the nurse was removing a bd intima ii¿ closed iv catheter system, the catheter was found to broken.An ultrasound and operation was carried out on the female (b)(6) patient to remove the broken catheter.It was reported that the patient was initially admitted for a cerebral infarction.There was no additional medical information reported.

• Brand Name: BD INTIMA II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR 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: 7076155
• MDR Text Key: 93503533
• Report Number: 3006948883-2017-00131
• 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,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 383407
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR