MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD 20G X 1.77IN (1.1 X 45 MM) ARTERIAL CANNULA WITH FLOWSWITCH

Catalog Number 682245

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: a sample was returned for evaluation but is pending evaluation.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6168238.A supplemental mdr will be filed upon completion of the investigation.

Event Description

It was reported that the nurse removed the dressing from the suspect device and found the hub had detached from the cannula.The cannula remained in the patient.The patient required vascular surgery to remove the retained device.

Manufacturer Narrative

Device evaluation: result - one used actual sample and one unused representative sample were returned for investigation.The used sample was evaluated and a broken catheter was observed.The broken catheter was potentially cut with a sharp object.The manufacturing process was reviewed.There is no process in the manufacturing facilities that could have caused this nonconformance.The manufacturing process includes an automated vision inspection machine that will reject parts not meeting lie distance requirements.A broken catheter will automatically be rejected as the lie distance will be out of specification.Therefore, this reported nonconformance could have occurred out of the manufacturing facilities.The representative sample was evaluated and no nonconformance was observed.Conclusion - bd was able to confirm the customer's indicated failure mode with the returned used sample.An absolute root cause for this incident cannot be determined.

• Brand Name: BD 20G X 1.77IN (1.1 X 45 MM) ARTERIAL CANNULA WITH FLOWSWITCH
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6250911
• MDR Text Key: 64792156
• Report Number: 8041187-2017-00002
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K850349
• 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: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 682245
• Device Lot Number: 6168238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention