MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22 GA X 1.0 IN. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 382623

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A sample is not available for evaluation.However, a photo investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the tubing of a 22 ga x 1.0 in.Bd insyte¿ autoguard¿ bc shielded iv catheter broke off in the patient¿s vein during iv infusion.Patient required an x-ray and ultrasound to find catheter.There is no report of surgery performed or scheduled for removal.

Manufacturer Narrative

Results: a sample was not available for evaluation.Customer photos were submitted for leakage, tubing defective/ damaged.In review of the photos, physical damage can be seen.A review of the device history record revealed no irregularities during the manufacture of the reported lot #7157661.All inspections were in compliance with requirements.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: 22 GA X 1.0 IN. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6972921
• MDR Text Key: 90081746
• Report Number: 1710034-2017-00262
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826231
• UDI-Public: 30382903826231
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 382623
• Device Lot Number: 7157661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• 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): Required Intervention