MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD VETERINARY SYRINGE, 3 ML BD LUER-LOK¿ SYRINGE WITH 22 G X 3/4 IN. NEEDLE; VETERINARY SYRINGE AND NEEDLE

Catalog Number 305662

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

The device being reported is specifically marketed for veterinary use.Therefore, it does not have an fda product code nor 510(k)#.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 as blood was being drawn from a dog's jugular vein with a bd veterinary syringe, 3 ml bd luer-lok¿ syringe with 22 g x 3/4 in.Needle, the dog moved and the needle detached from the hub and slid into the dog's jugular vein.The dog received an x-ray that showed the needle was in the lung.

Manufacturer Narrative

Results: one used sample and 55 sealed, unused samples were returned for evaluation.A microscopic inspection of the used sample revealed the cannula was missing from the hub.The cannula was not removed by epoxy failure but rather the cannula shaft broke apart just above the epoxy bead.The cannula shaft of 30 sealed samples were inspected to ensure that there were not defects that could have caused the customer¿s failure.The samples were inspected under a microscope.No defects or abnormalities to the cannula shaft was observed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6306791.Conclusion: although the customer's indicated failure mode was confirmed, an absolute root cause for this incident cannot be determined.Additionally, our quality engineer notes that this type of failure likely occurred due to bending of the cannula during injection.

• Brand Name: BD VETERINARY SYRINGE, 3 ML BD LUER-LOK¿ SYRINGE WITH 22 G X 3/4 IN. NEEDLE
• Type of Device: VETERINARY SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6487845
• MDR Text Key: 72656128
• Report Number: 1213809-2017-00021
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 05/10/2017

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: 305662
• Device Lot Number: 6306791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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