MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381212

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

The customer provided four potential lot numbers for this incident.The information for each lot number is as follows: medical device lot #: 6141428, medical device expiration date: 5/31/2021, device manufacture date: 5/20/2016.Medical device lot #: 6053154, medical device expiration date: 2/28/2021, device manufacture date: 2/22/2016.Medical device lot #: 5354408, medical device expiration date: 12/31/2020, device manufacture date: 12/20/2015.Medical device lot #: 6113190, medical device expiration date: 4/30/2021, device manufacture date: 4/22/2016.Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a 24 g x.75 in bd insyte¿ peripheral iv catheter broke off at the hub while it was being removed from a patient (a dog).The dog received several x-rays and it appears that the catheter is stuck in the dog's vein.No additional information was provided.

Manufacturer Narrative

Results: six unused samples in sealed packages were returned for evaluation.A visual inspection of all units revealed no abnormalities.A review of the device history records for the potential lot numbers 6141428, 6053154, 5354408, and 6113190 revealed no irregularities during the manufacturing process.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment that could have influenced the customer's reported issue.Conclusion: 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: 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• 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: 6535785
• MDR Text Key: 74145546
• Report Number: 8041187-2017-00040
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2017
• 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): Required Intervention